Label: ALCOHOL-FREE 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 13, 2022

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    Use to clean and decrease bacteria and germs.

  • Warnings

    • For external use only
  • WHEN USING

    When using this product

    • Keep out of eyes. In case of contact with eyes, flush throughly with water.
    • Avoid contact with broken skin.
  • STOP USE

    Stop use and ask a doctor if skin irritation develops.

  • 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

    • Lift tab on front of pack. Pull up wipe from center of pack. Replace cover. When not using, close center flap cover securely to prevert moisture loss.
    • Unfold wipe to wipe down. Let air dry. If area is extremely dirty, clean first with another wipe for best results. Dispose of wipe after each use.

  • Other information

    • Do not flush.
    • Rinse toys or food with clean water after cleaning.
    • Do not use as a diaper wipe or on sensitive skin.
    • Do not use on unpainted wood.
    • Do not use to clean dishes, glassware or utensils.
    • Store in original container in areas inaccessible to children.
    • Keep securely closed.
    • Do not reuse or refill this container.
    • Discard empty container in trash or recycle.
  • Inactive ingredients

    Bronopol, Ethylhexylglycerin, Didecyldimonium Chloride, Propylene Glycol, Glycerin, Purified Water, Perfume.

  • Package Label - Principal Display Panel

    15pcs label15pcs NDC: 79805-011-01

  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE WIPES 
    alcohol-free wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79805-011
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79805-011-0115 in 1 PACKET08/20/2020
    13.65 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/20/2020
    Labeler - JUXIN (Jiangsu) New Material Packaging Co., Ltd. (546994282)
    Establishment
    NameAddressID/FEIBusiness Operations
    JUXIN (Jiangsu) New Material Packaging Co., Ltd.546994282manufacture(79805-011)
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