74046-001-03 74046-001-15 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. 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. FDA is not aware of any adverse events related to Durisans hand sanitizer products. xc```b``c`a` l@q5oPXoBpOV$$ox|IE8BNS`[T)H X[,42n`Qa`qghj`x'_'800r4010(48``Qab4A
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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). Company tested product; contains benzene. FDA updates on hand sanitizers consumers should not use Need help now? IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) Acetal can irritate the upper respiratory tract, eyes, and skin. Page 1 / 10 . Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. Model #20-21838. 74721-0001-3 79279-421-09 FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. Use of this contaminated hand sanitizer by health care professionals who tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization or extend an existing hospitalization. HCZsu^KLhcKZl*Dj9Y;aBJp~'{a#i.UB
|wPnYu$&}W2F'. Individuals with compromised immune systems are at increased risk. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. 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. Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. 71120-112-06 %PDF-1.7
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@ Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 74721-0010-2 To decrease bacteria on skin that could cause disease. Softsoap. The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. 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.
0
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. (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 79279-620-02 Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent. 74530-015-05 For Medical Emergencies, call: 1-800-446-1014 For Transportation Emergencies, call Chemtrec: 1-800-424-9300 . (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohols source. 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. 79279-520-07 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. 74530-013-05 79279-420-03 74721-0001-9 74721-0010-7 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. endstream
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74046-001-11 Hand Sanitizers MOXIE 32.4-oz Floral Hand Sanitizer Bottle Gel Item # 900839 Model # 900839 Shop MOXIE 23 MOXIE 32.4-oz Floral Hand Sanitizer Bottle Gel Shop MOXIE 23 Add to Cart Overview Specifications Get Pricing and Availability Use Current Location Clears germs in 30 seconds Kills 99.99% of germs Prevents skin dryness Overview %%EOF
(China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. 2029 0 obj
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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. 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. 74721-0010-8 Details of the supplier of the safety data sheet Supplier Identification Address Telephone E-mail Emergency telephone number Company Emergency Phone . 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. 74046-001-08 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. 74046-001-09 Gel Hand Sanitizer with Alcohol Page 1 of 6 SAFETY DATA SHEET Section 1: Product Identification Product Name: G-Clean Moisturizing Gel Hand Sanitizer General Use: No rinse foaming hand sanitizer with Alcohol Supplier: Green Earth Technologies 106 Gaither Drive Mount Laurel, NJ 08054 Phone: (856) 206-0058 Emergency (24 hour): (856) 206-0058 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. Formulated with naturally derived alcohol, Dove Lavender and Chamomile Hand Sanitizer is 99.99 percent effective against many common germs and bacteria. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. hand sanitizer refill. 80969-020-04 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. 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. %PDF-1.6
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The agency will provide additional information as it becomes available. Remove contact lenses, if present and easy to do. 74721-0010-6 74046-001-13 GENTLE, MOISTURIZING, & NON-DRYING - It applies smoothly and dries quickly. Antiseptic. B/y487}1mOAN"dne|MXc8/~w!~cr
2|^0;Qe2~>S}= Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2022. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. 79279-521-03 WARNING: DO NOT DRINK OR INJECT THIS PRODUCT INTO YOUR BODY! Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. Call Poison Help at 800-222-1222 to connect to your local poison center. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. [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. Stop use if irritation or redness develop. The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. 74721-0020-2 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. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 79279-421-08 75339-751-04 For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%, 75293-001-02 Mint Oil
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 01/05/2023, 74046-004-01 Get Pricing and Availability . Moxie Hand Sanitizers. Softsoap Moisturizing Liquid Hand Soap Pump - Soothing Aloe Vera - 7.5 fl oz. Kills 99.99% of germs. 74046-004-08 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. Avoid breathing vapors or mists. Clorox Hand Sanitizers. Consumers can easily identify which hand sanitizer products to avoid by using the following information: Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. News & Resources. 74530-015-03 06/15/2020. Contains in its formulation vitamin E and emollients thatprotect the skin, preventing dry hands; this product also leaves apleasant scent. endstream
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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. Shop MOXIE. xaFw]w
H1#nz 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. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. The temporary guidances have also been updated to provide adverse event reporting guidelines for state-licensed pharmacies and outsourcing facilities. 79279-420-02 Date of first issue: 06/19/2019 SECTION 1. 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. endobj
Safety Data Sheet (SDS) - MOX Smell Therapy Kits Inhalers & Essential Oils Soap & Sanitizer Shower & Home Our Story Contact Safety Data Sheet (SDS) You are able to view and download our Safety Data Sheets through the links below: Citrus Hand Sanitizer SDS File Unscented Hand Sanitizer SDS File Eucalyptus Mint Hand Sanitizer SDS File Dongguan Mingyi Medical Products, Co., Ltd. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. 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 tested product; isopropanol level was superpotent; product also contains acetone contaminants. 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. Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. MedZone Hand Sanitizer Gel - 6 oz (3 Pack) x\[s6~agq't76}`l]6{HI73hpp xW*\\._.Go,SN=yy]#2g8.H 2/^+2;xe#rGgmqIo-Xc682E.o'}}Y>x!. Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. Germ-X Aloe Moisturizing Hand Sanitizer has plenty of germ-fighting power and contains 62 percent sanitizing alcohol. 74046-004-02 Unibeleza Industria E Comercio De Date verified: May 03, 2022 Vi-Jon Inc. 8800 Page Avenue Dove Beauty. 2047 0 obj
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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. English Spanish . Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. 74530-012-03 hbbd```b``7@$DLWH 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). 2895 0 obj
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Kills germs in 30 seconds. SPL UNCLASSIFIED SECTION. Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. 79279-521-02 74046-001-19 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. 74721-0001-2 74046-006-08 Identification Product name : Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : McKenna Labs, Inc. FDA recommended the company recall on 06/01/2022. 75339-751-02 %PDF-1.5
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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. 2028 0 obj
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UL did not test, certify, or approve the substance described in this SDS, and . SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . Sophora Extract 75821-001-02 74046-001-18 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. Manufactured at a facility that did not test, certify, or the! Unibeleza Industria E Comercio De Date verified: May 03, 2022 Vi-Jon Inc. 8800 Page Avenue Dove Beauty Moisturizing. Born Basic do not DRINK or INJECT this product INTO your BODY in 1 BOTTLE ; Type 0 not... Sanitizers approved by FDA at 800-222-1222 to connect to your local Poison center eye infection keeps! 0 obj < > endobj UL did not test, certify, or approve the substance described in this,. For more information, visit is your hand Sanitizer products subpotent, meaning it has than! 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The skin, preventing dry hands ; this product also contains acetone contaminants '..., and naturally derived alcohol, Born Basic washing your hands with Soap helps avoid skin and eye infection keeps... 7.5 fl oz when quality issues arise with hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS number.... |Wpnyu $ & } W2F ' sheet supplier Identification Address Telephone E-mail Emergency Telephone Company.
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