Label: ANTISEPTIC WIPES (benzalkonium chloride- 0.115% 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 August 4, 2020

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  • Active ingredients

    Benalkonium chloride (0.115%)

  • Purpose

    Antiseptic

  • Use

    Use to reduce bacteria on the skin

  • Warnings

    For external use only

  • Do Not Use

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

  • When using this product 

    When using this product do not use in or near eyes.

    In cases of contact, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    Stop use and ask a doctor if irritation or redness develops.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions:

    • Adults and children over 2 yeas of age:Apply to hands. Allow to dry without wioing.
    • Children under 2 year of age:ask doctor prior to use
  • Other information

    store below 110°F (43°C) May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Water, Glycerin, Aloe barbadensis leaf juice, Fragrance, 4Na EDTA,Propylene Glycol. sorbito

  • principal display panel

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  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC WIPES 
    benzalkonium chloride (0.115%) cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72308-028-2020 in 1 PACKAGE08/03/2020
    11 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
    2NDC:72308-028-4040 in 1 PACKAGE08/03/2020
    21 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
    3NDC:72308-028-8080 in 1 PACKAGE08/03/2020
    31 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2020
    Labeler - Flex Beauty Labs (080858917)
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