Label: ZIVA PERFUMED WIPES BAKHOOR- benzethonium 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 23, 2021

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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 sun light. Prevent contact with eyes. In case of irritation wash away with water immediately.

    Store below 25°C | For external use only | Keep out of reach of children

  • DOSAGE & ADMINISTRATION

  • KEEP OUT OF REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

  • Ingredients:

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

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ZIVA PERFUMED WIPES BAKHOOR 
    benzethonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81450-003
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SANTALUM ALBUM SEED OIL (UNII: J8A90C3A98)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81450-003-0110 in 1 PACKAGE12/24/2021
    13.42 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/24/2021
    Labeler - Ziva Wetwipes FZCo (559186188)
    Registrant - Dirra USA (117678868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ziva Wetwipes FZCO559186188manufacture(81450-003)
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