Label: DISINFECTANT WET WIPE- 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 January 28, 2022

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  • SPL UNCLASSIFIED SECTION

    Disinfectant wet wipe

  • Active Ingredient(s)

    Benzalkonium chloride 0.8mg/mL
    Cetylpyridinium Chloride 0.5mg/mL
    Didecyldimonium Chloride 0.32mg/mL

    Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Disinfectant wet wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

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

  • Do not use

    • in children 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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    • Wipe the body skin or other surface
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Glycerin
    Aloe Barbadensis Leaf Extract
    Chamomilla Recutita Flower Extract
    Decyl glucoside
    Aqua

  • Package Label - Principal Display Panel

    Label105070120

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT WET WIPE 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75111-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.8 mg  in 1 mL
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.32 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75111-301-0148 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:75111-301-02182 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:75111-301-03216 mL in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:75111-301-04302 mL 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 - Enping Jiaxin Daily Necessities Co., Ltd. (403010421)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enping Jiaxin Daily Necessities Co., Ltd.403010421manufacture(75111-301)