Label: ANTIBACTERIAL ANTISEPTIC WET WIPES 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 14, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.13% v/v ,

  • Purpose

    Antiseptic, Wet Wipes

  • Use

    decreases bacteria on skin For use when soap and water are not available

  • Warnings

    For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    when using this product do not get into eyes, ears and mouth ,If contact occurs, rinse thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours. these may be signs of a serious condition

  • 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 at 1-800-222-1222

  • Directions

    adults and children 2 years and over - apply to hands - wet hands thoroughly with product and allow it to dry

    Children under 2 years - ask a doctor before use

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat
  • Inactive ingredients

    deoinised water, Cetearyl isononanoate, Ceteareth-20, Cetearyl alcohol, glyceryl stearate, glycerine,cetearth-12, cetyl-palmitate, phenoxyethanol, sodium benzoate,fragrance, citric acid, disodium EDTA

  • Package Label - Principal Display Panel

    120 WIPES 120 wipes NDC: 81214-600-01

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL ANTISEPTIC WET WIPES 
    antibacterial antiseptic wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81214-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.03 mL  in 100 mL
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) 0.01 mL  in 100 mL
    CETEARETH-12 (UNII: 7V4MR24V5P) 0.01 mL  in 100 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.03 mL  in 100 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.01 mL  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.03 mL  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.03 mL  in 100 mL
    CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL  in 100 mL
    CETEARYL ISONONANOATE (UNII: P5O01U99NI) 0.03 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 99.52 mL  in 100 mL
    CETYL PALMITATE (UNII: 5ZA2S6B08X) 0.01 mL  in 100 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.03 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81214-600-01600 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2020
    Labeler - PRISTINE MK LLC (117674251)
    Registrant - FRESH CO COSMETICS SH.P.K (499428868)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRESH CO COSMETICS SH.P.K499428868manufacture(81214-600)
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