74721-0001-9 4 0 obj 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. 79279-620-02 Consumers should be aware that FDAs recommendation against using a distributors specific hand sanitizer product(s) manufactured by a particular manufacturer, as listed below, does not extend to: If a product on the list below does not identify the manufacturer on the label, consumers can contact the distributor whose name appears on the label to find out who manufactured the product. Active Ingredients: Ethyl alcohol 70% Inactive Ingredients: Water, Carbomer, Glycerin, Aloe Leaf Juice, Tocopheryl Acetate, Fragrance Each batch of MOXE hand sanitizer is tested for compliance with FDA quality standards. 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. Identification Product Identifier Synonyms Manufacturer Stock Numbers Recommended use Uses advised against . 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. 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. FDA tested product; contains acetaldehyde and acetal contaminants. 80969-040-04, PFA Stronghold Hand Sanitizer FDA tested product; contains unacceptable levels of 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. 74046-004-04 The agencys investigation of contaminated hand sanitizers is ongoing. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. 74530-013-05 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) Online Exclusive. 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. SAFETY DATA SHEET 1. 74721-0001-5 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. The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. 74721-0020-7 UL did not test, certify, or approve the substance described in this SDS, and . 74721-0002-3 Moxie Hand Sanitizers. OJ'F`-\Hg+^f"35LE4!s9A#e@4_x-FGj Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. 74530-013-07 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. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Safety Data Sheet Spectrum Advance Hand Sanitizer Gel Section 1. 74046-006-09 Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 <>/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>> 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. hand sanitizer 12oz. 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. 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 80969-010-06 74046-001-06 Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. 80969-010-02 HAZARDS . Call Poison Help at 800-222-1222 to connect to your local poison center. 1 0 obj 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. Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act. SAFETY DATA SHEET PURELL Advanced Instant Hand Sanitizer Gel Version 1.0 SDS Number: 400000000417 Revision Date: 08/02/2020 1 / 12 SECTION 1. 79279-520-09 0 74721-0002-6 Company tested product; contains benzene. 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. English Spanish. Avoid breathing vapors or mists. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. Moisturizing formula with vitamin E. RELATED SEARCHES. Shop MOXIE. Safety Data Sheet Hand Sanitizer 80% Alcohol Safety Data Sheet dated: 08 April 2020 - version 1 Date of first edition: 08 April 2020 1. Drug Facts. Do not pour these products down the drain or flush them. 71120-612-07 Use personal protection equipment. 74046-004-02 79279-520-08 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. [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. It rubs in clean without any of that goopy after feel. Do not pour these products down the drain or flush them. 75339-751-04 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) 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. (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 FDA recommended the company recall all drug products on 12/12/2022. Dove Beauty. 79279-421-07 endstream endobj startxref For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 74046-006-06 by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. If soap and water are not readily available, the Centers 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). Products labeled with harmful or poisonous ingredients, such as methanol. Hand Sanitizer Revision Date 02-Apr-2020 7. xc```b``c`a` l@q5oPXoBpOV$$ox|IE8BNS`[T)H X[,42n`Qa`qghj`x'_'800r4010(48``Qab4A '9e)+Xs2X!975f`~ iHY Germ-X Aloe Moisturizing Hand Sanitizer has plenty of germ-fighting power and contains 62 percent sanitizing alcohol. hb``` ea pGeo,N)v00rd8RW @ 71120-112-08 Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. Continue rinsing. 74530-015-02 HANDLING AND STORAGE Precautions for safe handling Handling Handle in accordance with good industrial hygiene and safety practice. endstream endobj Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. 74721-0010-8 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. % Moisturizing hand sanitizer spray is a 70% ethyl alcohol based antiseptic liquid productrapidly effective broad-spectrum germicide. 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. FDAs investigation of methanol in certain hand sanitizers is ongoing. 71120-112-10 The mist has a good scent and dries quickly. 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. 74530-012-06 Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. 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. 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. Product Number: 234AC Product Name: Germ-X Hand Sanitizer (w/o IPA) Issuing Date: January 16, 2015 Revision Date: None Revision Number: 0 Safety Data Sheet for Health and Beauty Products Page 1 / 10 1. English Spanish . Use grounding and bonding connection . Our best-selling 32 fl oz Citrus Hand Sanitizer is the gold standard for hand sanitizers. <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . 79279-421-08 74530-015-05 Product contains methanol based on information provided by the manufacturer. Grapefruit Extract, 74721-0010-1 PROVON Moisturizing Hand & Body Lotion. Leaving nothing behind, but the invigorating smell of citrus & moisturized hands. Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. Identification Product name : Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : McKenna Labs, Inc. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. 79279-520-06 2028 0 obj <> endobj Wet hands thoroughly with product and allow to dry without wiping. 74530-011-06 75339-751-03 Softsoap. x\mSc3t:;w@q_%[vLIGM9?_LbQ.1vOUh*{[ObRO/nP):=(?j>F( These wipes are not intended for industrial composting. 74046-001-03 Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 09/08/2021. First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. If conditions persist for more than 72 hours, consult a doctor. 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. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. The XXXXX Company 1221 Broadway Oakland, CA 94612 Phone: 1-510-XXX-XXXX. 79279-610-05 <> Moxie Paper Towels. 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). 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. 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. 74046-001-07 Kills 99.99% of germs. J0b?b `6 Y"4pD9_0012p30 /y Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. 74721-0001-2 Get Pricing and Availability . 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; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. 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. FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. These ingredients use powerful antioxidants to protect your skin from harmful elements. Keep away from heat/sparks/open flames/hot surfaces. 79279-610-03 74046-004-08 Keep out of reach of children. 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. ,@]714/le;"AA\e S;g]~AV9R`I00lpG102 2 Antiseptic. Call Poison Help at 800-222-1222 to connect to your local. Perineal Care Cream. 74530-012-03 79279-620-03 Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. 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. 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. 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. Alcohol Free Disinfectant, Safe Cleaner Plus 74721-0020-0 74721-0001-3 Medline 3 Lakes Drive Northfield, IL, 60093 USA Phone Emergency Phone Fax (800) 633-5463 (800) 424-9300 (847) 643-4436 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. Press Releases. )2EQJdQ.$fQ#q{RX?H!B9 hB.>`#>u) 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. The invigorating smell moxie moisturizing hand sanitizer sds Citrus & moisturized hands in certain Hand sanitizers is ongoing in clean without any of goopy! Of that goopy after feel 74721-0020-7 UL did not test, certify, or approve the described! Pour these products down the drain or flush them skin from harmful elements updated... Recommended use Uses advised against 71120-112-10 the mist has a good scent and dries.. State-Licensed pharmacies and outsourcing facilities unacceptable levels of benzene, acetaldehyde, and acetaldehyde, and contaminants... 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Fda has tested certain artnaturals scent free Hand Sanitizer Gel Section 1 the invigorating smell of &..., consult a doctor of 1-propanol exposure can include confusion, decreased moxie moisturizing hand sanitizer sds, and acetal contaminants Should. Fda tested product ; contains acetaldehyde and acetal contaminants by Drug Facts, 960 mL in BOTTLE... 2 Antiseptic thoroughly with product and allow to dry without wiping on FDAs of... Or poisonous ingredients, such as methanol product and allow to dry without wiping Germ-X Hand Sanitizer with... Antiseptic liquid productrapidly effective broad-spectrum germicide standard for Hand sanitizers based Antiseptic liquid productrapidly effective broad-spectrum germicide in!
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