Label: ALCOHOL DISINFECTANT WIPES- alcohol, chlorhexidine acetate, benzalkonium chloride cloth

  • NDC Code(s): 78183-008-01
  • Packager: Kunming Ansheng Industry & Trade Co., Ltd.
  • 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 24, 2020

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  • ACTIVE INGREDIENT

    75% alcohol

    0.1% chlorhexidine diacetate

    0.1% benzalkonium chloride

  • PURPOSE

    Antibacterial

    Antibacterial

    Antibacterial

  • INACTIVE INGREDIENT

    24.8% pure water

  • DIRECTIONS

    Open lid and pull tab.

    Pull out one wipe at a time for use.

    Reseal after use to prevent wipes from drying out.

  • USE

    Disinfecting wipes for all-purpose cleaning and safety cleaning hands.

  • WARNINGS

    • Flammable: keep away from open flame
    • For external use only.
    • Do not use on or around the eyes.
    • If irritation occurs, discontinue use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Contact medical help or poison control immediately,if swallowed
    Do not use on children less than two months of age.

  • PACKAGE LABEL

    80 a bag

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT WIPES 
    alcohol, chlorhexidine acetate, benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78183-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL750 mg
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78183-008-0180 in 1 BAG; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/17/2020
    Labeler - Kunming Ansheng Industry & Trade Co., Ltd. (421081801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kunming Ansheng Industry & Trade Co., Ltd.421081801manufacture(78183-008)