Label: 91% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid

  • NDC Code(s): 51628-4236-1, 51628-4236-2, 51628-4236-3
  • Packager: MY IMPORTS USA LLC
  • 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 May 5, 2022

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  • Drug Facts

  • Active ingredients (by volume):

    Isopropyl alcohol

    (91% conc.)

  • Purpose

    first aid antiseptic

  • Uses

    • First aid to help prevent the risk of infection in minor cuts, scrapes and burns

  • Warnings

    • For external use only; flammable, keep away from fire or flame, heat, spark, electrical, etc.

    Ask a doctor before use if you have

    • Deep punctured wounds, animal bites or serious burns

    When using this product

    • Do not get into eyes 

    • Do not apply over large areas of the body

    • Do not use longer than one week unless directed by a doctor

    Stop using this product if

    • Condition persists or gets worse

    Keep this drug out of the reach of children

    • In case of an accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately

  • Directions

    • Clean effected area

    • Apply small amount of this product on the area 1-3 times daily

    • May be covered with a sterile bandage

    • If bandaged, let dry first

  • Other information

    • Store at room temperature

    • Does not contain, nor is intended as a substitute for grain or ethyl alcohol. Will produce serious gastric disturbances if taken internally

  • Inactive Ingredient

    Water(Aqua)

  • SPL UNCLASSIFIED SECTION

    AS 9175

    Use only in a well ventilated area

    Fumes may be harmful

    WARNING FLAMMABLE

    keep away from fire or flame!

    91% by volume

    TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP SAFETY FOIL IS BROKEN OR MISSING

    Made in India

  • Packaging

    Label

  • INGREDIENTS AND APPEARANCE
    91% ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-4236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL91 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51628-4236-1355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    2NDC:51628-4236-2473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    3NDC:51628-4236-3946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/14/2021
    Labeler - MY IMPORTS USA LLC (195767988)
    Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt Ltd.726025211manufacture(51628-4236)
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