Label: BOSON- alcohol 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 July 30, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Ethyl Alcohol 75% 

  • Purpose

    Antibacterial

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use

  • Warnings

    For external use only - hands

    Flammable, keep away from heat and flame

    When using the product

    • keep out of eyes, in case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
  • 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

    • Wipe down surface thoroughly and allow to air-dry.
    • Discard wipe in trash receptacle after use, do not flush.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • Inactive ingredients

    Purified water, glycerin, ethylhexyl glycerin, phenoxyethanol, didecyldimonium chloride, propylene glycol, fragrance

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    BOSON 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53325-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53325-126-01100 in 1 CANISTER07/08/2020
    14.4 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2020
    Labeler - Almil Nutritional Products, Inc. (153736301)
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