74046-001-09 Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Grapefruit Extract, 74721-0010-1 Has been tested and is found to have microbial contamination. Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. Consumer and health care professional safety is a top priority for FDA, and an important part of FDAs mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply. 80969-010-06 74530-011-02 . 71120-112-06 <> Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 endstream endobj startxref ,@]714/le;"AA\e S;g]~AV9R`I00lpG102 2 Innovaciones Tecnologicas Concar, SA de CV 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 United States Pharmacopeia (USP) revised the Alcohol (ethyl alcohol) monograph on September 1, 2020, and established a limit for methanol in alcohol of 200 parts per million (ppm). If eye irritation persists: Get medical attention. Our best-selling 32 fl oz Citrus Hand Sanitizer is the gold standard for hand sanitizers. Benzene may cause certain types of cancer in humans. Cultivation Republic (Clearwater, Florida). 2918 0 obj <>stream fragrance free soap. 80969-007-01 Address : One GOJO Plaza, Suite 500 [10/28/2021] FDA is alerting health care professionals and consumers of artnaturals voluntaryrecall of limited batches of 8 oz bottles of Scent Free Hand Sanitizer. 74530-015-03 Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. 74530-015-06, 74530-011-01 [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. 74046-006-09 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. 74046-001-14 SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. 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. 74721-0010-6 74046-001-02 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): The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: FDA advises consumers not to use hand sanitizers produced by the manufacturers identified in the table below. 74721-0001-0 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. The agency urges consumers not to use these subpotent products and has expanded its list to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 79279-421-08 79279-620-03 74046-004-03 FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. Softsoap. Filter By . An official website of the United States government, : 74721-0002-1 The agency continues to add certain hand sanitizers to theimport alertto stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law. 74530-011-08, 74530-013-01 The small bottle size is perfect to fit nicely in a purse, glove box, small front pocket of backpack, etc, which makes it very convenient to have on hand most anywhere we go. Keep away from heat/sparks/open flames/hot surfaces. 63. 71120-112-05 1 0 obj Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. endobj US Phone: 866-748-9990 Fax: 413-513-1330 sales@safehands.com 866-748-9990. endstream endobj startxref hand sanitizer refill. 74530-013-04 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to thelistof hand sanitizers consumers should not use. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. 74046-001-08 Medline 3 Lakes Drive Northfield, IL, 60093 USA Phone Emergency Phone Fax (800) 633-5463 (800) 424-9300 (847) 643-4436 4 0 obj 74530-015-05 74046-006-06 74046-004-07 74046-001-03 FDA encourages health ce 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): [7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer productsthat are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. 79279-521-05 74046-001-13 Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. containers resembling food pouches labeled with childrens characters, including Barbie, Hot Wheels, Paw Patrol, Minions, JoJo Siwa Dreamer and Trolls World Tour, Hand sanitizer products packaged in containers resembling food pouches commonly used for childrens applesauce and other pureed foods that present increased risk of accidental ingestion by children; FDA recommended the distributor recall on 9/21/2020; this advisory does not extend to Smart Care products in other types of packaging; product voluntarily, Lite n Foamy Lemon Blossom Hand Sanitizer, Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020 and on 3/29/2021; FDA issued a, Company tested product; contains microbial contamination; product voluntarily recalled on 7/1/2020; FDA issued a, Private D Capital Group Corp., Human Choice LLC and RediBag USA Astrum LLC, Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/1/2020; added manufacturer to, SIREtizer Alcohol Antiseptic 80% Topical Solution Hand Sanitizer. Choose our Moisturizing Hand Sanitizer Wipes. 71120-112-11 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 9/2/2022. Grapefruit Extract, 74721-0001-1 Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. 79279-520-06 74046-001-05 Details of the supplier of the safety data sheet Supplier Address . Mint Oil x\[s6~agq't76}`l]6{HI73hpp xW*\\._.Go,SN=yy]#2g8.H 2/^+2;xe#rGgmqIo-Xc682E.o'}}Y>x!. 80969-010-02 75821-001-03 Call 9-1-1 if the person is unconscious or has trouble breathing. -. Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%, 75293-001-02 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. 79279-610-01 Purpose. 74721-0010-2 74046-001-17 Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. 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. 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. Call CHEMTREC: 1-800-424-9300 Do not pour these products down the drain or flush them. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. 74721-0020-6 79279-610-03 71120-612-06 Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. 74046-004-08 Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. 74721-0020-2 79279-610-02 The dangers of drinking any hand sanitizer under any conditions. Notice to manufacturers and distributors: If you believe your products are no longer within the labeled expiry period, are no longer in distribution, or you otherwise have information that your products no longer warrant inclusion on this list, you should provide your reasoning and supporting information for FDAs consideration toHSDoNotUseListInquiries@fda.hhs.gov. 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. Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? DISCLAIMER: These statements have not been evaluated by the FDA. Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. WARNING: DO NOT DRINK OR INJECT THIS PRODUCT INTO YOUR BODY! Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk. 74721-0001-3 Products labeled with harmful or poisonous ingredients, such as methanol. 3 0 obj Individuals with compromised immune systems are at increased risk. 74046-001-12 71120-112-10 74721-0001-8 Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. 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. Antibacterial Hand Sanitizer with Moisturize, Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. (China), Guangdong JunBao Industry Co. Ltd. (China), JPR Medical Disinfecting Wipes (75% alcohol), Guangdong JunBao Industry Co., Ltd. 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 11/29/2022. 74046-004-02 %PDF-1.6 % Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. Drug Facts. Remove contact lenses, if present and easy to do. (Michigan). 75339-751-04 hbbd```b``z"dd&{0 Lnf_etH2V!8_RDg1+@ $/ 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. Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. Flavor Vapors, LLC, dba: Mob Liquid Labs MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . 74046-006-02 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Sds Number: - 20ct of accidental ingestion more information on hazardous waste disposal for cross contamination with dangerous chemicals! 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