Label: BOSON- alcohol spray

  • 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 29, 2020

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  • Active Ingredient

    Ethanol Alcohol 75% v/v. 

  • Purpose

    Antiseptic

  • Use

    1. Hand disinfection - follow the standard method to use soap to wash hands, rinse with running water, dry with sterile towel, then direct spray this product on hands and forearms until moist, wait for 3 minutes, rub hands until dry.
    2. General object surface disinfection - directly spray on the object surface for until moist, waif for 3-5 minutes.
  • Warnings

    For external use only - hands
    Flammable, keep away from heat and flame
    Do not use

    • In children less than 2 months of age
    • On open skin wound

    When using the product 

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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • Extremely flammable
    • Seal for preservation, keep away from sunlight and don't expose to temperature exceeds 50C. Don't piece or burn
    • Don't spray on open flame or any flammable material. Keep it away from the reach of children.
    • Don't spray toward eyes
    • External disinfectant should not be taken orally and kept out the reach of children
    • Use with caution if allergic to alcohol
    • It should not be used to disinfect fat-soluble surfaces
    • The is product is irritating to wounds or mucous membranes
  • Inactive ingredients

    Purified water, glycerin, Hydrogen peroxide

  • Package Label - Principal Display Panel

    Label 1Label 2

    Label 3

  • INGREDIENTS AND APPEARANCE
    BOSON 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53325-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53325-125-01296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    2NDC:53325-125-02354.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    3NDC:53325-125-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2020
    Labeler - Aliml Nutritional Products, Inc. (153736301)