Label: ALCOHOL ANTIBACTERIAL WIPES cloth

  • NDC Code(s): 78183-015-01, 78183-015-02
  • 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 3, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    ethanol15.0%

    Chlorhexidine diacetate0.1%

    Benzalkonium chloride0.1%

  • Purpose

    Antibacterial

  • Use

    Hand Sanitizer to reduce bacteria on the skin

  • Warnings

    Flammable. Keep away from heat or flame

  • WHEN USING

    do not use in or contact the eyes or damaged skin

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    peel the sticker when you use it. Easily get one wipe at a time. After application, please re-seal the opening sticker firmly to prevent wipes from drying out

  • Inactive ingredients

    pure water

  • Package Label - Principal Display Panel

    5080

  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTIBACTERIAL WIPES 
    alcohol antibacterial wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78183-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.1 g  in 100 a
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 a
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL15 g  in 100 a
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78183-015-0150 a in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:78183-015-0280 a in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Kunming Ansheng Industry & Trade Co., Ltd. (421081801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kunming Ansheng Industry & Trade Co., Ltd.421081801manufacture(78183-015)