Label: ZIVA PERFUMED WIPES GARDENIA- benzethonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • Active Ingredient:

    Benzethonium Chloride 0.1%

  • PURPOSE

  • Direction for use

    Peel back the front label slowly. Pull wipes as needed. Reseal pouch by firmly running thumb over label to prevent moisture loss.

  • Precautions:

    For external use only. Do not apply to irritated or damaged skin. In case of gluteal erythema (redness of skin), contact your doctor or pharmacist. Keep in a cool place away from direct sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

  • DOSAGE & ADMINISTRATION

  • Keep out of reach of children

  • Other information

    Store below 25°C 

  • Ingredients:

    Aqua, Pentylene Glycol and Glyceryl Caprylate / Caprate, Perfume, PEG 40 Hydrogenated Castor Oil, Benzethonium Chloride, Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ZIVA PERFUMED WIPES GARDENIA 
    benzethonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81450-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GARDENIA JASMINOIDES FLOWER (UNII: 2TU49609L2)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81450-007-0110 in 1 PACKAGE12/24/2021
    13.42 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/24/2021
    Labeler - Ziva Wetwipes FZCo (559186188)
    Registrant - Dirra USA (117678868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ziva Wetwipes FZCO559186188manufacture(81450-007)
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