Label: ANTIBACTERIAL WET WIPES- benzalkonium chloride solution

  • 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 April 16, 2021

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.1%

  • PURPOSE

    ANTISEPTIC

  • USES

    FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEAT USE.

  • Warning

    • For external use only
    • Keep out of reach of eyes. If contact occurs, rinse throughtly with water.
    • Do not use if you are allergic to any of the ingredients.
    • Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.
    • Keep out of reach of children unless under adult supervision.
    • If swollowed, get medical help, or contact a Poison Control Center immediately.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN UNLESS UNDER ADULT SUPERVISION.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • Directions of Use

    Open resealabel label pull one sheetfrom pack. Thoroughly clean hands or affected area and discard in receptacle, and do not flush. Allow to dry without wiping. Be sure to reseal label complete to retain moisture.

  • INACTIVE INGREDIENTS

    Water, Opuntia Streptacantha stem Extract, Ethylhexylglycerin, Propylene Glycol, Benzethonium Chloride, Polyaminopropyl Biguanide

  • PRINCIPAL DISPLAY PANEL

    Runmei Paper_Happy Bum_Antibacterial Wet Wipes

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81472-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.01 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    OPUNTIA STREPTACANTHA STEM (UNII: 3TF9Z1U73O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81472-101-1010 in 1 POUCH; Type 0: Not a Combination Product04/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/16/2021
    Labeler - Runmei Paper (Fujian) Co., Ltd. (541535499)
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