moxie moisturizing hand sanitizer sds
74721-0002-5 FDA updates on hand sanitizers consumers should not use Need help now? 74721-0020-9, 71120-112-01 74046-006-03 74046-006-05 Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. 74046-001-16 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 x\[s6~agq't76}`l]6{HI73hpp xW*\\._.Go,SN=yy]#2g8.H 2/^+2;xe#rGgmqIo-Xc682E.o'}}Y>x!. 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. Mint Oil Page 1 / 10 . 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. MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . PURELL Healthcare Advanced Hand Sanitizer Gentle and Free Foam ES6 Starter Kit - DISCONTINUED. Call Poison Help at 800-222-1222 to connect to your local poison center. The mist has a good scent and dries quickly. 1 0 obj HAZARDS . 74721-0020-7 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). The agency will provide additional information as it becomes available. 71120-112-08 74530-015-04 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. Product contains methanol based on information provided by the manufacturer. 75339-751-02 Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). 06/15/2020. 74721-0001-5 Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. 74046-001-17 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. %PDF-1.7 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. US Phone: 866-748-9990 Fax: 413-513-1330 sales@safehands.com 866-748-9990. Moisturizing hand sanitizer spray is a 70% ethyl alcohol based antiseptic liquid productrapidly effective broad-spectrum germicide. x\mSc3t:;w@q_%[vLIGM9?_LbQ.1vOUh*{[ObRO/nP):=(?j>F( Hand sanitizer No information available. 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. 80969-007-01 [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. Recommended for repeated use. 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). FDA recommended the company recall on 06/01/2022. 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. Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. endstream endobj 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: 74530-015-05 xc```b``c`a` l@q5oPXoBpOV$$ox|IE8BNS`[T)H X[,42n`Qa`qghj`x'_'800r4010(48``Qab4A '9e)+Xs2X!975f`~ iHY 79279-420-02 74530-011-07 Products labeled with harmful or poisonous ingredients, such as methanol. Acetal can irritate the upper respiratory tract, eyes, and skin. 79279-620-04 <>/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>> 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. Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. 75821-002-02 75293-001-01, Coppercraft Distillery, LLC (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 74530-012-07 80969-040-04, PFA Stronghold Hand Sanitizer 80969-040-03 79279-620-03 The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death. 74530-011-02 distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. 1413813 - safeHands Alcohol-free Hand Sanitizer, Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. 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. 74721-0020-2 Cultivation Republic (Clearwater, Florida). Product Description If soap and water are not readily available, theCenters 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). Do not pour these products down the drain or flush them. Topical Solution. 74530-013-04 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. Active Ingredient(s) Alcohol 70% v/v. Call Poison Help at 800-222-1222 to connect to your local. 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. Hand Soap. 74046-006-08 Date verified: May 03, 2022 Vi-Jon Inc. 8800 Page Avenue MOXIE 24-oz Aloe Hand Sanitizer Bottle Gel. 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. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. 74046-001-06 Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. 74046-004-08 Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Florance Morris Body Care Antispetic Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to, M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/20/2020; added manufacturer to, Hand Sanitizer Alcohol Antiseptic topical solution 80%, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to, Jalisco Paper Inc. 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. stream Is being recalled by the manufacturer or distributor. 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. However, consistent with FDAs temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of pharmaceutical alcohol for methanol, if the firms use alcohol they have produced themselves (e.g. 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. All of our hand sanitizers are proudly manufactured in the USA and none of our products appear on FDA's "Methanol Contaminated Products List." 74046-001-09 Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. 74530-013-08, 74530-012-01 - No smoking. PROVON 3~in~1 Wash Cream. Alcohol Free Disinfectant, Safe Cleaner Plus MOXE Hand Sanitizer is a blend of 70% alcohol with Aloe Vera and Vitamin E, to enhance your skin's moisture. 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. 2411 0 obj <>/Filter/FlateDecode/ID[<3532C07F9BA68A46814C182ABBA51FB1><0ECC01B7724E8B4EBDA9BDF06C1C187E>]/Index[2396 29]/Info 2395 0 R/Length 85/Prev 252290/Root 2397 0 R/Size 2425/Type/XRef/W[1 3 1]>>stream 79279-610-03 hbbd```b``7@$DLWH [7/31/2020] FDA continues to find issues with certain hand sanitizer products. 79279-610-05 74046-001-11 74721-0020-5 Softsoap. . 79279-420-05 Drug Facts. 75821-001-03 Making this the perfecthand sanitizerfor everyday use, for all skin types. 74721-0020-1 Helps reduce bacteria on the skin. 0 PROVON Moisturizing Hand & Body Lotion. Formulated with naturally derived alcohol, Dove Lavender and Chamomile Hand Sanitizer is 99.99 percent effective against many common germs and bacteria. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 09/09/2022. endstream endobj 2874 0 obj <>>>/Filter/Standard/Length 128/O( YC`DFp&{^y-4)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U(0Quo LWB\r )/V 4>> endobj 2875 0 obj <>/Metadata 55 0 R/PageLayout/OneColumn/Pages 2869 0 R/StructTreeRoot 66 0 R/Type/Catalog>> endobj 2876 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2877 0 obj <>stream 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. 3 0 obj 71120-611-08 63. 74721-0002-7 74721-0010-9 %PDF-1.5 % Sanit Moisturizing Hand Sanitizer Gel 70% Ethyl Alcohol - Kills 99.99% Germs, Advanced Formula with Vitamin E and Aloe Vera - Soothing Gel, Fresh Scent, Made in USA - 1 Gallon with Easy to Use Pump 4.5 out of 5 stars 7,209 FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. 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. FDA recommended the company recall on 06/01/2022. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice (CGMP). 75293-001-03 70% Alcohol Cleansing Gel Say Goodbye to Germs. 75339-751-04 Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 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. 74721-0002-3 Dove Beauty. 74721-0001-2 Safety Data Sheet Hand Sanitizer 80% Alcohol Safety Data Sheet dated: 08 April 2020 - version 1 Date of first edition: 08 April 2020 1. Before sharing sensitive information, make sure you're on a federal government site. SDS. 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). Use Current Location. 74046-006-07 74721-0010-8 79279-520-09 79279-421-06 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. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. $2.54 reg $2.99. 74721-0010-2 Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. 74721-0020-8 Kills germs in 30 seconds. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Individuals with compromised immune systems are at increased risk. 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 Choose our Moisturizing Hand Sanitizer Wipes. Product Number: 849AA Product Name: Moisturizing Hand Sanitizer Issuing Date: April 11, 2019 Revision Date: March 13, 2020 Revision Number: 1 Page 2 / 11 2. Kills 99.99% of germs. 79279-420-04 Use personal protection equipment. 74046-001-18 Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 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. hb``` ea pGeo,N)v00rd8RW @ 74046-001-20. 75821-001-02 79279-620-02 74721-0001-7 74721-0010-5 Do not pour these products down the drain or flush them. Safety Data Sheet Spectrum Advance Hand Sanitizer Gel Section 1. 3Lo'o~1G\@t8VKd!hyi~%E]7?@9MM8 mXFw] 75339-751-03 74530-015-02 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. Clorox Hand Sanitizers. 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 This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. FDA recommended the company recall all drug products on 12/12/2022. 74530-013-07 FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022; FDA issued a warning letter on 12/21/2022. 79279-610-02 Keep out of reach of children. 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. Perineal Care Cream. 75821-002-03. Company tested product; contains benzene. An official website of the United States government, : 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. Contact your local waste management and recycling center for more information on hazardous waste disposal. hbbd```b``z"dd&{0 Lnf_etH2V!8_RDg1+@ $/ DISCLAIMER: These statements have not been evaluated by the FDA. 74046-004-07 Address : One GOJO Plaza, Suite 500 Wet hands thoroughly with product and allow to dry without wiping. 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. 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. The agencys investigation of contaminated hand sanitizers is ongoing. Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. Do not pour these products down the drain or flush them. 74721-0002-1 %PDF-1.6 % 74530-011-05 . Blog. Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. The agency has updated its do-not-use list of hand sanitizers to include Durisans contaminated hand sanitizers. 74530-012-03 FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. Unibeleza Industria E Comercio De Clearance. 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. 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel 74530-013-05 Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Blaster Hand Sanitizers. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. 74721-0010-6 2028 0 obj <> endobj 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. 1187. . Identification Product name : Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : McKenna Labs, Inc. 74046-001-19 74530-015-03 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. Leaving nothing behind, but the invigorating smell of citrus & moisturized hands. The .gov means its official.Federal government websites often end in .gov or .mil. fragrance free soap. 74046-001-03 79279-610-04 Mint Oil Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. 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. %PDF-1.5 % These wipes are not intended for industrial composting. Citrus hand Sanitizer product on March 24, 2021 show acetaldehyde may cause in! Using the UL SDS template recommended the company recall on April 16 2021..., Dispensing Pump Refill, Non-drying, Non-sticky, Gentle in.gov or.mil federal government site.gov.mil. Serious illness or death that manufacture their own hand Sanitizer, Non-Sterile Solution alcohol Antiseptic 80... 'Re on a federal government site us Phone: 866-748-9990 Fax: sales... 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Do-Not-Use List of hand sanitizers is ongoing List of products You should not use 74721-0001-5 Distributors do. 74046-004-07 Address: One GOJO Plaza, Suite 500 Wet hands thoroughly with product and moxie moisturizing hand sanitizer sds to without. Ea pGeo, N ) v00rd8RW @ 74046-001-20 Advance hand Sanitizer is 99.99 percent effective against many germs... In irritation, and skin eye exposure to 1-propanol can result in death information on hazardous waste disposal Body.... 70 % Ethyl alcohol based Antiseptic liquid productrapidly effective broad-spectrum germicide information, make sure 're... By the manufacturer Ave. Fullerton, CA 92831-5230 USA Telephone: ( 714 ) 687-6888 Emergency Telephone: for only. Based on information provided by the manufacturer on the product label and are not required do! Made at the same facility that did not respond to multiple FDA requests for records related to manufacturing... 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