Label: HAND WIPES- chlorhexidine gluconate and benzalkonium chloride swab

  • Category: HUMAN OTC DRUG LABEL

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 January 9, 2018

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  • Active ingredient

    CHLORHEXIDINE GLUCONATE 0.5%

    BENZALKONIUM CHLORIDE    0.08%

    Purpose

    Cleaning

  • Uses

    Cleans and refreshes hands and face without soap and water

  • Warnings

    For external use on hands only. Stop use and consult a doctor if skin irritation develops.
    Keep out of reach of children.

    Keep out of reach of children

    Keep out of reach of children

  • Directions

    Self-dries in seconds. Leaves skin soft and smooth.

  • INACTIVE INGREDIENT

    Glycerin, Kathon, TG, Purified Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HAND WIPES 
    chlorhexidine gluconate and benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.08 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61312-009-011 in 1 PACKAGE06/24/2017
    10.0418 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/24/2017
    Labeler - HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.526890634manufacture(61312-009)
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