Label: AIWINA ALCOHOL WIPES- ethyl alcohol cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 23, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 75%

  • Purpose

    Antiseptic

  • Indications and usage

    • For hand washing to decrease bacteria on the skin.

       Recommended for repeat use.

  • Warnings

    • For external use only.

    • Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

    • Do not use if you are allergic to any of the ingredients.

    • Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

    • Keep out of reach of children unless under adult supervision.

    • If swallowed, get medical help.

  • Directions of use

    • Wet hands thoroughly with product and allow to dry without rinse.

    • Children under six years of age should be supervised when using this product.

  • Other Information

    • Store in a dry place away from fire.

  • Inactive Ingredients

    • Water(Aqua), Propanediol, Aloe Vera Extract, IPBC, Dodecyl polyglucoside.

  • SPL UNCLASSIFIED SECTION

    KILL 99.9% OF GERMS & BACTERIA

    75% Alcohol

    STERILIZATION RATE OF 99.9% 

    DAILY CLEANING

    EFFECTIVE STERILIZATION

    EXQUISITE NON WOVEN FABRIC

    Made In China

    DISTRIBUTED BY

    ULTRA SOAP AZ LLC

    1445 east McKellips Rd.

    Tempe, ARIZONA 85281

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    AIWINA ALCOHOL WIPES 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79891-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79891-111-71240 in 1 CANISTER11/23/2020
    12.26 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/23/2020
    Labeler - DOBOLV (QUANZHOU) PAPER CO., LTD (550022046)
    Establishment
    NameAddressID/FEIBusiness Operations
    DOBOLV (QUANZHOU) PAPER CO., LTD550022046manufacture(79891-111)
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