Label: 95% ETHANOL (190 PROOF)- 95% alcohol solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 14, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient: Ethanol

  • PURPOSE

    Purpose:

    First aid antiseptic

  • INDICATIONS & USAGE

    Uses:

    helps prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    For external use only. If taken internally serious gastric disturbances will result.

    Flammable. Keep away from fire or flame, heat, spark, electrical

  • ASK DOCTOR

    Ask a doctor before use for deep or puncture wounds, animal bites or serious burns

  • WHEN USING

    When using this product

    • do not get into eyes
    • do not inhale
    • do not apply over large areas of the body
    • do not use longer than 1 week
  • STOP USE

  • STOP USE

    Stop use and ask doctor if condition persists or gets worse

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • INACTIVE INGREDIENT

    Deionized water

  • QUESTIONS

    Questions and Comments:
    www.bellechemical.com
    877-522-2233

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    95% ETHANOL (190 PROOF) 
    95% alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82771-950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL95 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82771-950-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/24/2022
    Labeler - Belle Chemical LLC (060891550)
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