Label: ANTIBACTERIAL MULIT-PURPOSE WIPES- benzalkonium chloride cloth

  • NDC Code(s): 77720-004-01, 77720-004-02, 77720-004-03, 77720-004-04, view more
    77720-004-05, 77720-004-06, 77720-004-07
  • Packager: Skaffles Group Limited Liability Company
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 29, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.3%

    Purpose

    Antibacterial

  • USE

    Decreases Bacteria on fur

  • Warning

    For external use only.

    Avoid Contact with eyes. Safe for dogs 8 weeks of age and older.

    Keep out of reach of children.

  • Directions

    Remove wipe from pouch and reseal to maintain freshness,

    wipe down dog from back of neck to tail,carefully avoiding the eyes ,didpose of wipe in trash ,do not flush

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    11

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL MULIT-PURPOSE WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:77720-004
    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)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77720-004-0120 in 1 POUCH
    14.05 g in 1 NOT APPLICABLE
    2NDC:77720-004-0230 in 1 POUCH
    24.05 g in 1 NOT APPLICABLE
    3NDC:77720-004-0350 in 1 POUCH
    34.05 g in 1 NOT APPLICABLE
    4NDC:77720-004-0450 in 1 CANISTER
    44.05 g in 1 NOT APPLICABLE
    5NDC:77720-004-05100 in 1 POUCH
    54.05 g in 1 NOT APPLICABLE
    6NDC:77720-004-0675 in 1 CANISTER
    64.05 g in 1 NOT APPLICABLE
    7NDC:77720-004-0775 in 1 POUCH
    74.05 g in 1 NOT APPLICABLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2020
    Labeler - Skaffles Group Limited Liability Company (831115642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Qimei Commodity Co., Ltd544331136manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Lonza Guangzhou Nansha LTD545328150api manufacture
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