Label: GERM OUT ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • NDC Code(s): 72308-025-20, 72308-025-60
  • Packager: Flex Beauty Labs LLC
  • 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 August 27, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DRUG FACTS

  • Active Ingredients

    Benzalkonium chloride 0.13%

    Purpose

    Antibacterial

  • Use

    To reduce bacteria on the skin.

  • Warnings

    For external use only.

    DO NOT USE

    if you are allergic to any of the ingredients.

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    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 years of age: Apply to hands, Allow to dry without wiping. Children under 2 years of age: ask doctor prior to use.

  • Other information:

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

  • Inactive Ingredients:

    Water (Aqua), Glycerin, Phenoxyethanol, Polysorbate 20, Sodium PCA, Fragrance (Parfum), Ethylhexylglycerin, Tocopheryl Acetate (Vitamin E), Aloe Barbadensis Leaf Extract, Tetrasodium EDTA, Citric Acid.

  • Package Labeling:20ct

    Label

  • Package Labeling:60ct

    Box

  • INGREDIENTS AND APPEARANCE
    GERM OUT ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72308-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72308-025-2020 in 1 PACKET08/15/2020
    13.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:72308-025-6060 in 1 PACKET08/15/2020
    23.2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/15/2020
    Labeler - Flex Beauty Labs LLC (080858917)