Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers. 79279-521-05 75821-002-03. The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use. 74721-0010-8 74721-0020-9, 71120-112-01 FDA reminds consumers to 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. 74721-0020-7 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. 74721-0001-8 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Benzene may cause certain types of cancer in humans. 74721-0002-7 It rubs in clean without any of that goopy after feel. Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. hb``` ea pGeo,N)v00rd8RW @ Innovaciones Tecnologicas Concar, SA de CV Stop use if irritation or redness develop. A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 74530-015-05 Avoid breathing vapors or mists. To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. The mist has a good scent and dries quickly. Company tested product lot 2004090090; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022. Kills germs in 30 seconds. 63. 2424 0 obj <>stream 79279-610-03 74046-001-17 Before sharing sensitive information, make sure you're on a federal government site. The agency also included an additional denaturant formula in the temporary guidances. 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. 74530-012-04 First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. Do not pour these products down the drain or flush them. Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> 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. Hand Sanitizer SAFETY DATA SHEET Date of Preparation: March 17, 2020 Page 2 of 10 IF IN EYES: Rinse cautiously with water for several minutes. SAFETY DATA SHEET PURELL Advanced Instant Hand Sanitizer Gel Version 1.0 SDS Number: 400000000417 Revision Date: 08/02/2020 1 / 12 SECTION 1. %%EOF Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. 74530-015-04 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. 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. 71120-611-07 Drug Details . The XXXXX Company 1221 Broadway Oakland, CA 94612 Phone: 1-510-XXX-XXXX. FDA tested product; contains acetaldehyde and acetal contaminants. endstream endobj Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. 74530-011-02 2029 0 obj <> endobj 2031 0 obj <>/MediaBox[0 0 612 792]/Resources<>/XObject<>>>/StructParents 0/Tabs/S/Type/Page/CropBox[0 0 612 792]/Rotate 0/Parent 2021 0 R>> endobj 2032 0 obj <>stream Keep away from heat/sparks/open flames/hot surfaces. 75821-001-02 All of our hand sanitizers are proudly manufactured in the USA and none of our products appear on FDA's "Methanol Contaminated Products List." 80969-007-01 Unibeleza Industria E Comercio De 79279-421-09 xaFw]w H1#nz Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Details of the supplier of the safety data sheet Supplier Identification Address Telephone E-mail Emergency telephone number Company Emergency Phone . FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 Amazon.com : MOXE Premium Eucalyptus & Mint Hand Sanitizer Value Pack - Calming Moisturizing Waterless Antiseptic Cleanser with 70% Ethyl Alcohol, Aloe Vera & Essential Oils - Fights Germs & Bacteria - 4 x 32oz : Health & Household Health & Household Health Care First Aid Antibiotics & Antiseptics Hand Sanitizers Currently unavailable. FDA recommended the company recall on 06/01/2022. These products are not intended to diagnose, treat, cure, or prevent any disease. 74046-001-11 SAFETY DATA SHEET 1. Antiseptic. 74046-006-05 74046-006-03 Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile, 1 Quart, 32 FL OZ (0.95 L), Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution, Gel, 8 FL OZ (250 ml), Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution. Herbacil Antiseptic Hand Sanitizer 70% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily, Soho Fresh Hand Sanitizer Gel Antibacterial, FDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to, SOHO Fresh Hand Sanitizer Gel Antibacterial, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/15/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; Product voluntarily recalled by, CALA Advanced Hand Sanitizer with Aloe Vera Extract, FDA-tested product; contains benzene; FDA recommended the company recall Lot 2004718 (Expiration 04/2023) on 12/27/2021; FDA expanded recall on 2/25/2022 to include all hand sanitizer drug products manufactured at the facility; added manufacturer to, Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced, FDA tested product; contains methanol; product retained at the border; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, DEPQ Internacional S de RL de CV (Mexico), FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, dgreen Advanced Hand Sanitizer Antibacterial Gel, Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to, FDA tested product; contains methanol; addedmanufacturerto, Product purported to be made at the same facility that produced methanol contaminated product; addedmanufacturerto, Distribuidora Lagunera del Norte SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Distribuidora Lagunera del Norte SA de CV, FDA tested product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, Cleaner by Crystalware Hand Sanitizer Alcohol Gel, FDA tested product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to, The Good Gel Antibacterial Gel Hand Sanitizer, CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, Estrategia Hospitalaria SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to, Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/8/2020; added manufacturer to, Genesis Partnership Company SA (Guatemala), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/27/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to. 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