Cosmeticos Ltda, (Brazil), Biotipo Pharma Medical Antibacterial Antiseptic Cleanser Disinfectant, 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 10/18/2022, Reborncare Hand Sanitizer (100mL, 250mL, 500mL). 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. 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. Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. Safety Data Sheet Spectrum Advance Hand Sanitizer Gel Section 1. 74046-006-02 (Michigan). 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. The testing method (with appropriate validation) can be used for hand sanitizers labeled with either alcohol (ethanol) or isopropyl alcohol (also called isopropanol or 2-propanol) as the active ingredient and can screen for potentially harmful impurities, as listed in FDAs temporary guidances. 74046-006-10. (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 endstream endobj startxref Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. SAFETY DATA SHEET PURELL Advanced Instant Hand Sanitizer Gel Version 1.0 SDS Number: 400000000417 Revision Date: 08/02/2020 1 / 12 SECTION 1. 74721-0020-9, 71120-112-01 Keep away from heat/sparks/open flames/hot surfaces. Address : One GOJO Plaza, Suite 500 74530-015-02 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel 71120-112-05 Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. 71120-112-11 Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. It rubs in clean without any of that goopy after feel. 2 0 obj Stop use if irritation or redness develop. Helps reduce bacteria on the skin. 74721-0020-5 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. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. 75293-001-03 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. FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. Online Exclusive. Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. 74530-015-04 endstream endobj (China). 74046-001-20. These wipes are not intended for industrial composting. hand sanitizer 12oz. 80969-010-06 endstream endobj 2874 0 obj <>>>/Filter/Standard/Length 128/O( YC`DFp&{^y-4)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U(0Quo LWB\r )/V 4>> endobj 2875 0 obj <>/Metadata 55 0 R/PageLayout/OneColumn/Pages 2869 0 R/StructTreeRoot 66 0 R/Type/Catalog>> endobj 2876 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2877 0 obj <>stream %PDF-1.5 % fragrance free soap. 74721-0002-3 79279-520-07 71120-611-07 79279-521-02 74530-013-07 74721-0010-2 %PDF-1.7 74046-006-04 74046-004-02 Remove contact lenses, if present and easy to do. FDA recommended the company recall on 06/01/2022. Choose our Moisturizing Hand Sanitizer Wipes. 74721-0010-8 Recommended for repeated use. 74530-011-07 Artnaturals Hand Sanitizer Infused with Jojoba Oil, Germ Free Anti-Bacterial Instant Hand Sanitizer, Apollo Instant Hand Sanitizer Anti Bacterial, Health & Wellness Essentials Hand Sanitizer Wash-Free, New Sanicol Advanced Antibacterial Hand Sanitizer, National Travel Products, Inc (New Jersey), 74530-015-01 74721-0002-7 Germ-X Aloe Moisturizing Hand Sanitizer has plenty of germ-fighting power and contains 62 percent sanitizing alcohol. SAFETY DATA SHEET Kleenex Ultra Moisturizing Foam Hand Sanitizer Version 1.0 Revision Date: 02/25/2020 SDS Number: N00103460403 Date of last issue: - Date of first issue: 02/25/2020 Carbon dioxide (CO2) Unsuitable extinguishing media : Water spray jet Specific hazards during fire fighting : Highly flammable liquid and vapor. Guangzhou Minghui Cosmetics Co. Ltd. (China), 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; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021, Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. 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 5/16/2022; FDA issued a warning letter on 07/20/2022. 75339-751-02 Antiseptic. 74721-0002-6 FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; FDA issued a warning letter on 01/30/2023. FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. 75821-001-03 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. Hand Soap. J0b?b `6 Y"4pD9_0012p30 /y Shop MOXIE. Uses. 79279-521-05 Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. PROVON 3~in~1 Wash Cream. The .gov means its official.Federal government websites often end in .gov or .mil. The mist has a good scent and dries quickly. At Target, find a wide range of hand . Moisturizing Hand Sanitizer $7.95. First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 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. 74046-004-09 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. Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. 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. 79279-610-02 News & Resources. 79279-521-01 74046-004-08 Softsoap. Individuals with compromised immune systems are at increased risk. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. Use grounding and bonding connection . 2424 0 obj <>stream 80969-010-07 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. <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 16 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Supplier Address Vi-Jon Inc. 8800 Page Avenue Saint Louis MO 63114 US Supplier Phone Number Phone: 314 -427 1000 (M-F 8am-4pm CST) Fax:3144271010 Continue rinsing. Products labeled with harmful or poisonous ingredients, such as methanol. Company tested product; 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 Associated lot numbers: Company tested product lot 200423322; 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. Grapefruit Extract, 74721-0010-1 Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 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. 79279-420-05 Place directly on hand and rub in thoroughly. OJ'F`-\Hg+^f"35LE4!s9A#e@4_x-FGj 75339-751-04 hand sanitizer refill. 74046-001-15 79279-610-05 Sophora Extract 74046-001-06 Company tested product; contains benzene. 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. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. The agency will provide additional information as it becomes available. Call 9-1-1 if the person is unconscious or has trouble breathing. 74046-001-16 75821-001-02 74530-013-06 Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. 80969-040-03 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. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. FDA is not aware of any adverse events related to Durisans hand sanitizer products. Medline 3 Lakes Drive Northfield, IL, 60093 USA Phone Emergency Phone Fax (800) 633-5463 (800) 424-9300 (847) 643-4436 Consumers who have products on thelist of hand sanitizerswith potential contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. %%EOF FDA updates on hand sanitizers consumers should not use Need help now? Consumers who have products on thelist of hand sanitizerswith potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. 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. 2028 0 obj <> endobj 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. 1 0 obj 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). 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. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. Cart 74721-0020-6 For Medical Emergencies, call: 1-800-446-1014 For Transportation Emergencies, call Chemtrec: 1-800-424-9300 . 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). An official website of the United States government, : If eye irritation persists: Get medical attention. Keep out of reach of children. 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. While USP has not yet updated the Isopropyl Alcohol Monograph to include a specific methanol limit, FDA may consider the 200 ppm methanol limit for ethanol to also be suitable for isopropyl alcohol. These products are not intended to diagnose, treat, cure, or prevent any disease. Call CHEMTREC: 1-800-424-9300 HCZsu^KLhcKZl*Dj9Y;aBJp~'{a#i.UB |wPnYu$&}W2F'. GENTLE, MOISTURIZING, & NON-DRYING - It applies smoothly and dries quickly. 74530-011-03 79279-620-01 Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. 3Lo'o~1G\@t8VKd!hyi~%E]7?@9MM8 mXFw] 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. 75293-001-04 Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. DISCLAIMER: These statements have not been evaluated by the FDA. %%EOF 74046-006-08 75339-751-03 74721-0001-7 80969-040-04, PFA Stronghold Hand Sanitizer Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP Alcohol monograph. 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. Date of first issue: 06/19/2019 SECTION 1. MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . 71120-112-06 63. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 74046-001-02 FDA issued, Alcohol Isopropilico Hand Sanitizer Limar, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/16/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/30/2021;product, Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to, BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to, MODESA Instant Hand Sanitizer Moisturizers and Vitamin E, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily, BLUMEN Advanced Instant Hand Sanitizer Lavender, BLUMEN Clear LEAR Advanced Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer Aloe, BLUMEN Clear Advanced Instant Hand Sanitizer Lavender, BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol, Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol, Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol, Blumen Antibacterial Fresh Citrus Hand Sanitizer, Hello Kitty Hand Sanitizer; this is not an official Sanrio licensed product, Assured Instant Hand Sanitizer (Vitamin E and Aloe), Assured Instant Hand Sanitizer (Aloe and Moisturizers), Assured Instant Hand Sanitizer Vitamin E and Aloe, Assured Instant Hand Sanitizer Aloe and Moisturizers, BLUMEN Instant Hand Sanitizer Fragrance Free, FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to, bio aaa Advance Hand Sanitizer 480 mL bottles, Product purported to made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/26/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily, NuuxSan Instant Antibacterial Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily, Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers, Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E, Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/31/2020; added manufacturer to, Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to, DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages), SBL Brands LLC dba Global Sanitizers LLC (Nevada) LLC dba Global Sanitizers LLC (Nevada), Protz Real Protection Antibacterial Hand Sanitizer, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product, 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, AltaioHand Sanitizing Wipes (80% Ethanol), 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;addedmanufacturerto, AltaioHand Sanitizing Wipes (70% Ethanol), Naturia Professional Green Hand Sanitizer, Essentials by Urban Secrets Hand Sanitizer, Essentials by Urban Secrets Advanced Hand Sanitizer, Botanicals Internacional SA de CV (Mexico), Alcohol Antiseptic 80% topical solution hand sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Inatek Hand Sanitizer Non-Sterile Solution 70% of Alcohol, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to, Total Pure Alcohol Based Hand Sanitizer Gel, Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi). 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