Label: ANTIBACTERIAL HAND WIPES- 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 December 4, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.3%

    Purpose

    Antibacterial

  • USE

    For hand washing to decrease bacteria on the skin.
    Recommended for repeated use.

  • Warning

    Do not use
    If you are allergic to any of the ingredients. In the eyes; if contact occurs, rinse thoroughly with water.
    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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

  • Directions

    Directions● Adults and children 2 yrs and over,
    apply to hands and allow skin to dry without wiping.
    ●Children under 2, ask doctor before use.

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Cetylpyridinium Chloride, Chamomilla Recutita(Matricaria)Flower Extract, Citric Acid, Disodium Cocoamphodiacetate, Disodium EDTA, PEG-75 Lanolin,PEG-8Dimethicone,Phenoxyethanol,Potassium Sorbate, Quatermium-52, Sodium Benzoate, Water.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    QUATERNIUM-52 (UNII: 588EQF3H1P)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77720-013-0120 in 1 CARTON12/10/2020
    150 in 1 CANISTER
    14.05 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/10/2020
    Labeler - Skaffles Group Limited Liability Company (831115642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Qimei Commodity Co.,Ltd. 544331136manufacture(77720-013)
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