Label: ANTIBACTERIAL WIPES- benzalkonium chloride swab

  • 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 June 18, 2020

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  • INACTIVE INGREDIENT

    Deionized Water, Tetrasodium EDTA, Sodium Cocoamphoacetate, Glycerin, Dehydroacetic Acid,
    Phenoxyethanol, Benzoic Acid, D-Panthenol, Fragrance, Aloe Barbadensis Leaf Juice, Daisy Extrac

  • PURPOSE

    Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN

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

  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.2% w/w

  • WHEN USING

    • do not use in or near the eyes
    • In case of eye contact, hold eyes open and rinse slowly and gently with water.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DO NOT USE

    • on broken skin
    • if you are allergic to any of the ingredients.
  • ASK DOCTOR

    Stop use and ask a doctor if, too much skin irritation or sensivity develops or increases.

  • DOSAGE & ADMINISTRATION

    adults and children 2 years and older: wipe hands and allow to dry without wiping.
    children under 2 years: ask a doctor before use.

  • INDICATIONS & USAGE

    for hand sanitizing to reduce bacteria on the skin.

  • WARNINGS

    For external use only.

  • PRINCIPAL DISPLAY PANEL

    Full DesignDrug FactsFrontSide

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79084-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79084-001-0160 in 1 PACKAGE06/25/2020
    1100 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/25/2020
    Labeler - GULSELI TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (505259407)
    Registrant - GULSELI TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (505259407)
    Establishment
    NameAddressID/FEIBusiness Operations
    GULSELI TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI505259407manufacture(79084-001)
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