74721-0020-8 Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. (Florida), Salon Technologies International Sanitizing Hand Spray 80%. Use personal protection equipment. Product Description 80969-010-06 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. 74721-0010-2 GENTLE, MOISTURIZING, & NON-DRYING - It applies smoothly and dries quickly. Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. 74046-006-10. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. Call a POISON CENTER or doctor if you feel unwell. Before sharing sensitive information, make sure you're on a federal government site. 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. 74721-0001-7 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. x\mSc3t:;w@q_%[vLIGM9?_LbQ.1vOUh*{[ObRO/nP):=(?j>F( 74721-0010-5 Leaving nothing behind, but the invigorating smell of citrus & moisturized hands. 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. (Nevada), Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022, Salon Technologies International Date verified: May 03, 2022 Vi-Jon Inc. 8800 Page Avenue The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. Unibeleza Industria E Comercio De 74530-013-07 Need help now? And it doesn't dry your skin. 79279-421-06 75821-002-03. 2873 0 obj <> endobj 80969-040-03 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). 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). 75821-001-04 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. Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. endstream endobj 2397 0 obj <>/Metadata 48 0 R/Pages 2394 0 R/StructTreeRoot 58 0 R/Type/Catalog>> endobj 2398 0 obj <>/MediaBox[0 0 612 792]/Parent 2394 0 R/Resources<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2399 0 obj <>stream HANDLING AND STORAGE Precautions for safe handling Handling Handle in accordance with good industrial hygiene and safety practice. 74721-0001-0 (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 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. 79279-420-03 Products labeled with harmful or poisonous ingredients, such as methanol. Individuals with compromised immune systems are at increased risk. It rubs in clean without any of that goopy after feel. 71120-611-08 hUmk0+}4aJ?Hlgt;ys|;G0"E &jT.u#0jp0\_qtiI"z &x%MIXzmWouAyIxOF]8OI]Td9N[Gu*ID9~*/>][]%(6=cmV:QE&yeW6DsNMv^oC\GRV=b]t Wn\Erx'yQN7q@B@,KCwa0UCR9Z5(R/iYYOg}HeQ]~\>*BZ#Xq1! ! O B{\32Dyu#a6Rd2O};. 79279-620-02 distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. Hand Sanitizer Sprays Full-Size Sanitizers Hand Sanitizer Holders Gentle & Clean Hand Soaps Hand Soaps & Sanitizers 216 Items 1 2; 3; Next Page; Filter By. If conditions persist for more than 72 hours, consult a doctor. These products are not intended to diagnose, treat, cure, or prevent any disease. 74530-015-05 Kills 99.99% of germs. Choose our Moisturizing Hand Sanitizer Wipes. )2EQJdQ.$fQ#q{RX?H!B9 hB.>`#>u) Product Name 746AA Germ-X Advanced Original Hand Sanitizer Other means of identification Product Code(s) N/A . Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent. <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> endobj 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. 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. 74046-001-19 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. 74721-0010-9 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. 74721-0001-6 Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. Mint Oil 71120-112-05 Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. 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. Product contains methanol based on information provided by the manufacturer. 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. Details of the supplier of the safety data sheet Supplier Identification Address Telephone E-mail Emergency telephone number Company Emergency Phone . SAFETY DATA SHEET PURELL Advanced Instant Hand Sanitizer Gel Version 1.0 SDS Number: 400000000417 Revision Date: 08/02/2020 1 / 12 SECTION 1. Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. Germ-X Aloe Moisturizing Hand Sanitizer has plenty of germ-fighting power and contains 62 percent sanitizing alcohol. Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. 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. 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. MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . 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. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. 74721-0020-6 Mint Oil 74530-012-06 x\[s6~agq't76}`l]6{HI73hpp xW*\\._.Go,SN=yy]#2g8.H 2/^+2;xe#rGgmqIo-Xc682E.o'}}Y>x!. 74046-006-05 2028 0 obj <> endobj 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 agency will provide additional information as it becomes available. Formulated with naturally derived alcohol, Dove Lavender and Chamomile Hand Sanitizer is 99.99 percent effective against many common germs and bacteria. 75339-751-03 Identification Product Identifier Synonyms Manufacturer Stock Numbers Recommended use Uses advised against . Details of the supplier of the safety data sheet Supplier Address . 74046-001-07 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. 2047 0 obj <<11d8443039ffb9595ea092986c7d9186>]>>stream <>/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>> Page 1 / 10 . SAFETY DATA SHEET 1. %PDF-1.7 FDA tested product; contains unacceptable levels of acetaldehyde and acetal;Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023. 79279-420-04 79279-620-03 Kills germs in 30 seconds. 75293-001-04 80969-010-07 (China). 74721-0020-5 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. Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. HCZsu^KLhcKZl*Dj9Y;aBJp~'{a#i.UB |wPnYu$&}W2F'. Add to Bag previous product image next product image. Emergency telephone number Emergency Phone Numbers . Keep out of reach of children. 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. 74721-0010-7 FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. 74046-001-09 Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%, 75293-001-02 Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. 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. Product purported to be made at the same facility that produced product containing acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) 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. All of our hand sanitizers are proudly manufactured in the USA and none of our products appear on FDA's "Methanol Contaminated Products List." PROVON 3~in~1 Wash Cream. 80969-010-02 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. 74721-0020-7 FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. FDA 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. FDA is not aware of any adverse events related to Durisans hand sanitizer products. <> If eye irritation persists: Get medical attention. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. 74046-006-03 75821-001-02 The agency also reminds manufacturers of their ongoing obligation, in accordance with current good manufacturing practice (CGMP) requirements, to take all appropriate actions to prevent unsafe levels of methanol in drugs, including, but not limited to, purchasing alcohol or isopropyl alcohol from a reliable supplier, completing proper testing of alcohol or isopropyl alcohol, and reviewing finished product test methods to verify the testing distinguishes between the active ingredient and methanol. SPL UNCLASSIFIED SECTION.
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