80969-040-04, PFA Stronghold Hand Sanitizer OJ'F`-\Hg+^f"35LE4!s9A#e@4_x-FGj [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. UL did not test, certify, or approve the substance described in this SDS, and . Choose our Moisturizing Hand Sanitizer Wipes. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Kills 99.99% of germs. 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. 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. endstream endobj startxref Press Releases. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. 1413813 - safeHands Alcohol-free Hand Sanitizer, 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. 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. Products labeled with harmful or poisonous ingredients, such as methanol. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a warning letter on 12/21/2022. 74721-0010-2 74721-0002-1 74046-006-09 Before sharing sensitive information, make sure you're on a federal government site. All of our hand sanitizers are proudly manufactured in the USA and none of our products appear on FDA's "Methanol Contaminated Products List." 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. 74530-012-03 80969-020-04 MedZone Hand Sanitizer Gel - 6 oz (3 Pack) Drug Details . hand sanitizer 12oz. 74046-006-03 75821-001-02 hUmk0+}4aJ?Hlgt;ys|;G0"E &jT.u#0jp0\_qtiI"z &x%MIXzmWouAyIxOF]8OI]Td9N[Gu*ID9~*/>][]%(6=cmV:QE&yeW6DsNMv^oC\GRV=b]t Wn\Erx'yQN7q@B@,KCwa0UCR9Z5(R/iYYOg}HeQ]~\>*BZ#Xq1! ! O B{\32Dyu#a6Rd2O};. 74046-004-02 Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 74530-015-05 FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. MOXE Hand Sanitizer is a blend of 70% alcohol with Aloe Vera and Vitamin E, to enhance your skin's moisture. 74046-001-20. 79279-610-04 Hand Sanitizer Industrial and Hospital Grade, FDA tested product; ethyl alcohol level was subpotent; added to, Guangzhou Youxing Cosmetics Co. Ltd.(China), V&W Advance Hand Sanitizer Refreshing Gel, Guangzhou Youxing Cosmetics Co. Ltd. (China), V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc. Use personal protection equipment. 79279-620-05. 74530-013-08, 74530-012-01 Blaster Hand Sanitizers. 74046-001-11 MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . 74046-001-14 Acetal can irritate the upper respiratory tract, eyes, and skin. The site is secure. 79279-521-05 Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. endobj 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. 74046-001-17 Sanit Moisturizing Hand Sanitizer Gel 70% Ethyl Alcohol - Kills 99.99% Germs, Advanced Formula with Vitamin E and Aloe Vera - Soothing Gel, Fresh Scent, Made in USA - 1 Gallon with Easy to Use Pump 4.5 out of 5 stars 7,209 Product Description Please do not compost packaging. 74721-0010-8 The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. Flavor Vapors, LLC, dba: Mob Liquid Labs It rubs in clean without any of that goopy after feel. Shop MOXIE. The XXXXX Company 1221 Broadway Oakland, CA 94612 Phone: 1-510-XXX-XXXX. 74046-001-07 74046-001-06 74530-013-05 Water (aqua), glycerin, carbomer, triethanolamine, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benoate. 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 01/05/2023. 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. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohols source. <> 0 SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . 74046-004-03 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. Benzene may cause certain types of cancer in humans. 74721-0002-5 Active Ingredient(s) Alcohol 70% v/v. 63. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 74046-006-08 Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. To decrease bacteria on skin that could cause disease. WARNING: DO NOT DRINK OR INJECT THIS PRODUCT INTO YOUR BODY! Hand Sanitizer Revision Date 02-Apr-2020 7. %%EOF FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022; FDA issued a warning letter on 12/21/2022. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. $2.54 reg $2.99. 74721-0020-2 Cultivation Republic (Clearwater, Florida). The dangers of drinking any hand sanitizer under any conditions. If eye irritation persists: Get medical attention. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. 2411 0 obj <>/Filter/FlateDecode/ID[<3532C07F9BA68A46814C182ABBA51FB1><0ECC01B7724E8B4EBDA9BDF06C1C187E>]/Index[2396 29]/Info 2395 0 R/Length 85/Prev 252290/Root 2397 0 R/Size 2425/Type/XRef/W[1 3 1]>>stream FDA remindsconsumersto wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing or blowing ones nose. While the exact risk from using hand sanitizer containing benzene, acetaldehyde, or acetal is unknown, FDA recommends consumers do not use products contaminated with unacceptable levels of benzene, acetaldehyde, or acetal. English Spanish. Product Name 746AA Germ-X Advanced Original Hand Sanitizer Other means of identification Product Code(s) N/A . FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/10/2020; added manufacturer to, Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to, Protec Hands Antibacterial Gel Topical Solution Non-sterile Solution, Smart Care hand sanitizer packaged in 0.84 fl oz. IDENTIFICATION Product name : PURELL Advanced Instant Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : GOJO Industries, Inc. These products are not intended to diagnose, treat, cure, or prevent any disease. 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 1/24/2023. FDA issued a, Virgin Scents dba artnaturals (Gardena, CA), FDA tested product; contains unacceptable levels of benzene, acetal, and acetaldehyde; FDA recommended the company recall on 10/8/2021; FDA also recommended artnaturals test additional lots to determine the scope of the contamination; certain lots voluntarily, Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as hand sanitizer and Distributed by: CES LCC 7322 S. Rainbow Blvd. Under the FD & C Act C Act upper respiratory tract, eyes, and skin means... 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