Label: AIWINA SANITIZING WET WIPES- alcohol, benzalkonium chloride 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 June 17, 2020

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  • Active Ingredients

    Benzalkonium Chloride 0. 10%

    Alcohol 75%

  • Purpose

    Antiseptic, Hand Sanitizer

  • Uses

    • 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

    • 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), Glycerol, Propanediol, Aloe Vera Extract, Amino acid moisturizer, Hexadecylpyridinium Chloride, Vitamin E, Citric acid, Sodium citrate, Dodecyl polyglucoside.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    AIWINA SANITIZING WET WIPES 
    alcohol, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79011-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BETAINE (UNII: 3SCV180C9W)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79011-001-8080 in 1 CANISTER06/18/2020
    14.25 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/18/2020
    Labeler - HONGKONG YIFAR INDUSTRIAL LIMITED (663840571)
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