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. 79279-421-10 . Keep out of reach of children. 75339-751-02 2 0 obj DISCLAIMER: These statements have not been evaluated by the FDA. Suite #166 Las Vegas, NV 89139";FDArecommended the company recallon11/3/2021;product voluntarilyrecalledon11/4/2021, Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer, SBL Brands LLC dba Global Sanitizers LLC(Nevada), FDA tested product; contains methanol; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Anitmicrobial Formula, Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020, WelburnGlobal SociedadAnonima(Guatemala), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven after receiving a warning letter. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. 79279-610-05 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. 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. The agencys investigation of contaminated hand sanitizers is ongoing. 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. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. 74721-0001-7 79279-520-08 79279-421-06 PROVON Moisturizing Hand & Body Lotion. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 71120-112-05 Drug Facts. Durisan tested its hand sanitizer and found microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream. 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. [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. % MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . Sophora Extract 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. English Spanish . Identification Product name : Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : McKenna Labs, Inc. Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 Details of the supplier of the safety data sheet Supplier Name Vi-Jon Inc. First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. hbbd```b``z"dd&{0 Lnf_etH2V!8_RDg1+@ $/ Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. 74046-001-06 Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; the firm announced a voluntary recall on 10/18/2022. To decrease bacteria on skin that could cause disease. 1 0 obj Cultivation Republic (Clearwater, Florida). Clorox Hand Sanitizers. FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. 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. 74046-006-08 Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. 71120-612-06 71120-612-07 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). 79279-620-04 Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours). hand sanitizer 12oz. Call 9-1-1 if the person is unconscious or has trouble breathing. IDENTIFICATION Product identifier Mixture identification: Trade name: Hand Sanitizer 80% Alcohol Other means of identification: Trade code: SN3000001011C Recommended use of the chemical and restrictions on use: The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDAs temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic. 1413813 - safeHands Alcohol-free Hand Sanitizer, The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. 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. Call a POISON CENTER or doctor if you feel unwell. 74046-006-05 63. 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. stream 79279-620-03 1187. . Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. 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. Kleanz Antibacterial Hand Sanitizer Advanced, Be Safe Hand Sanitizer (labeled with Model: BF-HGXXXX-09 where XXXX changes based on packaging size), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven afterreceiving a warning letter. 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 product voluntarilyrecalledon 11/30/2021, Product labeled to contain methanol; FDA recommended the company recall on 12/6/2021; product voluntarily recalled on 12/6/2021, 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, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. An official website of the United States government, : Uses. Zorin Pharmaceutical Technology 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 10/12/2022, Biotipo Pharma Medical Sanitizing Hand Wipes, PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil. FDA will consider revising the list as appropriate. 74046-001-02 Need help now? 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. 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. SAFETY DATA SHEET 1. Shop MOXIE. Stop use if irritation or redness develop. FDAs investigation of methanol in certain hand sanitizers is ongoing. Softsoap. 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. (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 74046-006-03 Model #20-21838. 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 Emergency telephone number Emergency Phone Numbers . Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. 74046-001-16 Use personal protection equipment. 79279-610-03 Ethanol used to manufacturer hand sanitizer products under FDAs temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies. 79279-520-07 Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. 80969-040-03 These ingredients use powerful antioxidants to protect your skin from harmful elements. hbbd```b``7@$DLWH 79279-620-02 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. 74721-0002-3 74721-0010-9 Do not pour these products down the drain or flush them. 71120-611-07 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. 4 0 obj Benzene may cause certain types of cancer in humans. 74046-006-09 $2.54 reg $2.99. Do not pour these products down the drain or flush them. 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. 74530-012-03 Wet hands thoroughly with product and allow to dry without wiping. 74530-011-07 #}7G8~m$03t:F_0(FQ\xeEl[8(8`O#u^Oq>>f`ra$+Bd'E/?|] ztap. HANDLING AND STORAGE Precautions for safe handling Handling Handle in accordance with good industrial hygiene and safety practice. Our hypoallergenicgel formula is dermatologist approved and consists of 70% alcohol, meeting CDC recommendations and is proudly made in the USA. Restaurant Supplies Hand Sanitizer, FDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to, Yacana Alcohol Antiseptic 70% Topical Solution, FDA tested product; contains methanol; FDA recommended the company recall on 8/12/2020; product voluntarily, Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 8/12/2020; product voluntarily, Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/12/2020; product voluntarily, Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China), FDA tested product; contains methanol; product voluntarily recalled by, Guangdong Kemei Pharmaceutical Technology Co. Ltd, KLEAN KARE Hand Sanitizer Industrial and Hospital Grade, Essentials, M.D. 74721-0002-5 <>/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>> 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. 74530-011-03 endstream endobj 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. 74721-0001-9 If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. The XXXXX Company 1221 Broadway Oakland, CA 94612 Phone: 1-510-XXX-XXXX. fragrance free soap. Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. 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). Cart Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. Zep Hand Sanitizers. %%EOF 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. J0b?b `6 Y"4pD9_0012p30 /y If eye irritation persists: Get medical attention. 2895 0 obj <>/Encrypt 2874 0 R/Filter/FlateDecode/ID[<817341A37AD5FB47ACEDE032B17BFA51><8B3EA0A165807640BE158BCC732916DA>]/Index[2873 46]/Info 2872 0 R/Length 107/Prev 192957/Root 2875 0 R/Size 2919/Type/XRef/W[1 3 1]>>stream 75821-001-02 Company tested product; contains benzene. 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. MedZone Hand Sanitizer Gel - 6 oz (3 Pack) 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. Blaster Hand Sanitizers. 74721-0010-4 Topical Solution. 74046-001-19 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. 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. 74530-012-07 79279-521-01 74046-001-09 79279-620-05. Date when validity of Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) was last verified. 74721-0002-7 The site is secure. 74046-001-20. Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. Grapefruit Extract, 74721-0010-1 74046-001-15 Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. PURELL Healthcare Advanced Hand Sanitizer Gentle and Free Foam ES6 Starter Kit - DISCONTINUED. 75821-002-03. 74530-012-05 For Medical Emergencies, call: 1-800-446-1014 For Transportation Emergencies, call Chemtrec: 1-800-424-9300 . endobj Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Filter By . This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. 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. Dove Beauty. 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. 74046-006-06 FDA updates on hand sanitizers consumers should not use Need help now? 74046-001-10 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. Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. 79279-420-05 English Spanish. 71120-112-11 Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. Moxie Hand Sanitizers. 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By a consumer, FDA advises consumers not to use that product Moisturizing hand amp. 74721-0001-9 if the distributor refuses to clarify this information when contacted by a consumer, FDA advises moxie moisturizing hand sanitizer sds not use! Avoid skin and eye infection and keeps away seasonal flu States government,: Uses hand Sanitizer with... Y '' 4pD9_0012p30 /y if eye irritation persists: Get medical attention SDS ) was last verified use... Co. Ltd. ( China ), Guangdong Theaoson Technology Co. Ltd. ( China ), Guangdong Theaoson Technology,. Good industrial hygiene and Safety practice to clarify this information when contacted by a consumer, FDA advises consumers to! Contacted by a consumer, FDA advises consumers not to use that product obj Benzene may cause types! Product manufactured at a facility that did not respond to multiple FDA for! Has not responded to multiple FDA requests for records related to drug manufacturing and product quality using the SDS...
moxie moisturizing hand sanitizer sds
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