Label: BABY WIPES- benzalkonium chloride cloth

  • NDC Code(s): 76906-005-01
  • Packager: Zhejiang BeiTao Hygienic Products 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 May 27, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antiseptice Handwash

  • USE

    For sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.

  • Warning

    For external use only

    When using this product, avoid contact with eyes. In case of contact, flush eyes thoroughly with water

    Stop use and ask a doctor if irritation and redness develop.

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

  • Directions

    Take wipe and rub thoroughly to cleanse

    Wait and let dry

    Dispose of wipe

  • Inactive ingredients

    Aqua,Glycerin,Phenoxyethanol,Polysorbate 20,Benzoic Acid,Aloe Barbadensis Leaf Juice,Cetylpyridinium Chloride.

  • PRINCIPAL DISPLAY PANEL

    80 piece NDC 76906-005-01 80 piece

  • INGREDIENTS AND APPEARANCE
    BABY WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76906-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76906-005-0180 in 1 POUCH05/28/2020
    11 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/28/2020
    Labeler - Zhejiang BeiTao Hygienic Products Co., Ltd. (412925352)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang BeiTao Hygienic Products Co., Ltd.412925352manufacture(76906-005)
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