Suite #166 Las Vegas, NV 89139";FDArecommended the company recallon11/3/2021;product voluntarilyrecalledon11/4/2021, Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer, SBL Brands LLC dba Global Sanitizers LLC(Nevada), FDA tested product; contains methanol; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Anitmicrobial Formula, Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020, WelburnGlobal SociedadAnonima(Guatemala), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven after receiving a warning letter. Hand Sanitizer Revision Date 02-Apr-2020 7. Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. 74046-004-09 (Michigan). 74530-012-03 74046-001-07 )2EQJdQ.$fQ#q{RX?H!B9 hB.>`#>u) endobj FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product): [3/25/2021] FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination. Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. 79279-610-01 74721-0020-5 Anti-Bac Hand Sanitizer 65% Alcohol, Scent Theory Keep It Clean Pure Clean Anti-bacterial Hand Sanitizer, Cavalry (labeled with Product of Mexico), Natural Gold Gel Alcohol Antiseptic 75% Topical Solution, Command Gel AntiBac Instant hand sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 7/31/2020; product voluntarily, UltraCruz Hand Sanitizing Gel Antimicrobial, Company tested product; isopropyl alcohol level was subpotent; product voluntarily recalled lot BF12530 on 8/7/2020, Sanit Technologies LLC, doing business as Durisan (Florida), Durisan Antimicrobial Solutions Hand Sanitizer, Alcohol-Free, Company tested product; contains microbial contamination; product, Durisan Antimicrobial Solutions Hand Sanitizing Wipes, Alcohol-Free, New Wave Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%), Company tested product; manufacturing process lacks adequate controls to prevent microbial contamination. 74721-0020-1 Kills germs in 30 seconds. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. ], Alcohol Antiseptic 75% Topical Solution Hand Sanitizer, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to, Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico), HF&N Lab Medi Care Alcohol Antiseptic Topical Solution, 77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Medically Minded Hand Sanitizer Gel Antimicrobial Formula, SBL Brands LLC dba Global Sanitizers LLC (Nevada), Alcohol Antiseptic 70% Solution or 80% Solution, Pacific Coast Global Inc. and Tritanium Labs LLC, FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to, TriCleanz (labeled with Made in Mexico), TriCleanz Tritanium Labs Hand Sanitizer (labeled with Made in Mexico), Cklass Hand Sanitizer With Aloe Enriched With Moisturizing Emollient Agents, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Industrias Cklass Foaming Hand Sanitizer with Aloe, Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to, Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75%, EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer, Ismar Soluciones Dinmicas S de RL de CV (Mexico), Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to, Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel, MVP Sanitizing Services Spray Hand Sanitizer, Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily, Leipers Fork Distillery Bulk Disinfectant per 5 gallon and Leipers Fork Distillery 16 oz bottle, Product labeled to contain methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 8/3/2020, FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to, FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to, Liqesa Exportacion or Liq-E-SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added manufacturer to, Optimus Lubricants Instant Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; company is not registered with FDA; additional products may be on the market; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added manufacturer to, The Crme Shop Moisturizing Hand Sanitizer, Peppermint Scented, FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to, Company tested product; contains methanol; product voluntarily recalled by, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily, Product purported to be made at the same facility that produced 1-propanol contaminated product; FDA recommended the company recall on 8/17/2020; product voluntarily, Neoingenium Labs SA de CV Hand sanitizer (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 9/11/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to, Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China), Best Brand Consumers Products, Inc. (New York), Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022;added manufacturer to, FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations, Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to, FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Noticias Mexico Hoy Grupo Multimedia (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls; added manufacturer to, Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product, Precision Analitica Integral SA de CV (Mexico), FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to, Quimica Magna de Mexico SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; added manufacturer to, Product purported to be made at the same facility that produced subpotent product; added manufacturer to, Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer, Real Clean Distribuciones SA de CV (Mexico), Born Basic. Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; the firm announced a voluntary recall on 10/18/2022. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAsMedWatch Adverse Event Reportingprogram (please provide the agency with as much information as possible to identify the product): [8/7/2020] Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDAs temporary policies to help ensure that harmful levels of methanol are not present in these products. Product purported to be made at the same facility that produced subpotent ethyl alcohol product;added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued awarning letteron 07/06/2021. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. Innovaciones Tecnologicas Concar, SA de CV 75293-001-03 70% Alcohol Cleansing Gel Say Goodbye to Germs. 74530-015-04 Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. hbbd```b``z"dd&{0 Lnf_etH2V!8_RDg1+@ $/ SAFETY DATA SHEET Page 1 of 7 SECTION 1: IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING 1.1 Product Identifier Trade Name Moxie 6 -0 4 May 30, 2018SDS Date 1.2 Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Product Use: Foliar Nutrient To be used only where there is a recognized need. Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. Products labeled with harmful or poisonous ingredients, such as methanol. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. 74046-001-02 Item #889085. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated,FDA urges consumers not to drink any of these products. USPs revision bulletin for alcohol and dehydrated alcohol monographs outlines this testing requirement, official as of September 1, 2020, which FDA requested to protect health care providers and consumers from using dangerous hand sanitizer products. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. If soap and water are not readily available, theCenters for Disease Control and Prevention(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol). Recommended for repeated use. FDA is not aware of any adverse events related to Durisans hand sanitizer products. Hand Soap. endobj J0b?b `6 Y"4pD9_0012p30 /y HAZARDS . Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Germ-X Aloe Moisturizing Hand Sanitizer has plenty of germ-fighting power and contains 62 percent sanitizing alcohol. Gel Hand Sanitizer with Alcohol Page 1 of 6 SAFETY DATA SHEET Section 1: Product Identification Product Name: G-Clean Moisturizing Gel Hand Sanitizer General Use: No rinse foaming hand sanitizer with Alcohol Supplier: Green Earth Technologies 106 Gaither Drive Mount Laurel, NJ 08054 Phone: (856) 206-0058 Emergency (24 hour): (856) 206-0058 74530-012-05 71120-112-05 FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 09/27/2022; product voluntarily recalled on 9/27/2022. UL did not test, certify, or approve the substance described in this SDS, and . Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. Details of the supplier of the safety data sheet Supplier Name Vi-Jon Inc. 2 0 obj Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 74046-006-05 74046-006-10. Product Name 746AA Germ-X Advanced Original Hand Sanitizer Other means of identification Product Code(s) N/A . Consumers can easily identify which hand sanitizer products to avoid by using the following information: Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. Call Poison Help at 800-222-1222 to connect to your local. Softsoap. US Phone: 866-748-9990 Fax: 413-513-1330 [email protected] 866-748-9990. FDA recommended the company recall on 9/20/2021;product voluntarily recalled on 9/21/2021, SBL Brands LLC dba Global Sanitizers, LLC (Nevada), Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA issued a, Scentsational Soaps and Candles Inc. (Florida), Scentsational Sanitizer Non-Sterile Solution Alcohol Antiseptic 70% Topical Solution, Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily, Fresh Lemon Citron Frais Scented Hand Sanitizer, SS Black and White Collection and Photo Real Collection: Coconut Breeze; Eucalyptus & Mint; Lavender & Herbs; Lemon Zest; Tangerine & Guava, Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 1/20/2022; product voluntarily recalled on 1/28/2022. 71120-611-08 They're 99.9% effective against many germs and made with 100% plant-based fibres, which are developed to break down when home composted and meet ASTM D6868 standards for compostability. 74046-001-14 Ethanol used to manufacturer hand sanitizer products under FDAs temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies. These products are not intended to diagnose, treat, cure, or prevent any disease. distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. 74046-001-17 Topical Solution. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA updates on hand sanitizers consumers should not use, 10/12/2021: FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers, 10/4/2021: UPDATE - FDA advises consumers not to use certain artnaturals hand sanitizers, local waste management and recycling center, Centers for Disease Control and Prevention, 3/25/2021: UPDATE - FDA warns consumers not to use Durisan Antimicrobial Solutions recalled Hand Sanitizer Alcohol-Free due to microbial contamination, 1/26/2021: PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers, 1/19/2021: UPDATE - FDA Provides Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During COVID-19 Public Health Emergency, 8/27/2020 PRESS RELEASE - COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers, 8/24/2020: UPDATE FDA provides testing method to assess the quality of hand sanitizer products for impurities, 8/12/2020: UPDATE - FDA expands hand sanitizer warnings to include 1-propanol contamination, 8/7/2020: UPDATE - FDA Includes Methanol Testing in Temporary Policies for Alcohol-Based Hand Sanitizers, 7/31/2020: UPDATE - FDA continues to find issues with certain hand sanitizer products, 7/27/2020 PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products, 7/2/2020: UPDATE- FDA warns consumers of risk of methanol contamination in certain hand sanitizers, 7/2/2020 PRESS RELEASE - FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, 6/19/2020 ALERT - FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem. The agency also included an additional denaturant formula in the temporary guidances. This hand sanitizer delivers 8 hours of moisturization and has Moisture Renew Blend moisturizers that go deep into the surface layers of your skin for instantly softer hands. 75339-751-06, Dongguan Chunzhen Biological Technology Co., Ltd(China), GuangdongLongtaiIndustry Co., Ltd.(China), Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/05/2022, GuangdongLongtaiIndustry Co., Ltd.(China), Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 07/06/2022, Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China), Guangzhou Minghui Cosmetics Co. Ltd.(China). 79279-610-04 74046-004-03 71120-612-06 The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDAs temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic. 1413813 - safeHands Alcohol-free Hand Sanitizer, 75339-751-03 However, consistent with FDAs temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of pharmaceutical alcohol for methanol, if the firms use alcohol they have produced themselves (e.g. PROVON 3~in~1 Wash Cream. 79279-620-03 FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. 74046-001-18 74530-011-03 FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAsMedWatch Adverse Event Reportingprogram (please provide the agency with as much information as possible to identify the product): [1/19/2021] Today, FDA issued a guidance outlining the agencys policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products. 74721-0001-2 HAND SANITIZER Isopropyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; contains benzene; FDA recommended the company recall Lot 200324 (expiration date unknown) on 03/30/2022, Product labeled to contain methanol; FDA recommended the company recall on 11/18/2021. 75339-751-05 B/y487}1mOAN"dne|MXc8/~w!~cr 2|^0;Qe2~>S}= 74046-004-02 Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. FDA updates on hand sanitizers consumers should not use Need help now? FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. 79279-420-02 Page 1 / 10 . Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. Moisturizing Gel Hand Sanitizer Moisturizing Gel and Waterless Hand Sanitizer Our antimicrobial and waterless hand sanitizer is formulated with 62% ethyl alcohol (by weight) as well as emollients and moisturizers to help improve skin health with continued use. 74530-015-06, 74530-011-01 News & Resources. 79279-421-06 endstream endobj startxref 80969-007-01 79279-521-03 80969-010-06 74721-0001-6 Company tested product; contains benzene. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination. 74046-001-16 Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. Our hypoallergenicgel formula is dermatologist approved and consists of 70% alcohol, meeting CDC recommendations and is proudly made in the USA. 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