Label: MULTI-PURPOSE ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • NDC Code(s): 79531-003-01, 79531-003-02, 79531-003-03
  • Packager: Supreme Premium Products,Inc.
  • 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 July 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial Agent

  • Use

    Decreases bacteria on skin.

  • Warnings

    For external use only.

  • Do not use

    Do not use if you are allergic to any of the ingredients.

  • WHEN USING

    Using this product do not get into eyes. lf 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.

  • 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.

  • Directions

    Open using a label attached, pull out the wipe, and then seal the opening by sticking back the label to prevent the wipe from drying out.

  • Other information

    The expiry date is stated on the packaging, Store at -20℃ to +30℃,away from sunlight.

  • Inactive ingredients

    C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Aqua.

  • Package Label - Principal Display Panel

    label-15label-15-2

    label-60label-60-2label-75

  • INGREDIENTS AND APPEARANCE
    MULTI-PURPOSE ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79531-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) (UNII: G258TFN61X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79531-003-0177 g in 1 BAG; Type 0: Not a Combination Product07/11/2020
    2NDC:79531-003-02295 g in 1 BAG; Type 0: Not a Combination Product07/11/2020
    3NDC:79531-003-03435 g in 1 PAIL; Type 0: Not a Combination Product07/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/11/2020
    Labeler - Supreme Premium Products,Inc. (610328981)
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