Label: ALCOHOL ANTIBACTERIAL WIPES 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 11, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v;

    Chlorohexidine Diacetate 0.1% v/v;

    Benzalkonium 0.1% v/v;

  • Purpose

    Antibacterial

  • Use

    For hand sanitizing to decrease bacterial on the skin.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • on infants less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    1, Open sticker, pull out the wipe and close sticker tightly.

    2, Dispose of used wipes in trash, DO NOT FLUSH.

  • Other information

    Keep in cool dry place, storage temperature: 0-40℃

  • Inactive ingredients

    Inactive ingredients: Water, Chlorohexidine Diacetate, Benzalkonium Chloride

  • Package Label - Principal Display Panel

    30 wipes in one bag. NDC: 78183-018-01

    50 wipes in one bag. NDC: 78183-018-02

    30wipes

    50wipes

  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTIBACTERIAL WIPES 
    alcohol antibacterial wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78183-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 U  in 1 U
    Inactive Ingredients
    Ingredient NameStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) 0.001 U  in 1 U
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.001 U  in 1 U
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78183-018-0130 U in 1 BAG; Type 0: Not a Combination Product06/01/2020
    2NDC:78183-018-0250 U in 1 BAG; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Kunming Ansheng Industry & Trade Co., Ltd. (421081801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kunming Ansheng Industry & Trade Co., Ltd.421081801manufacture(78183-018) , label(78183-018)
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