Label: ISOPROPYL RUBBING ALCOHOL 99%- isopropyl alcohol liquid

  • NDC Code(s): 52000-030-01, 52000-030-02, 52000-030-03, 52000-030-04, view more
    52000-030-05, 52000-030-06, 52000-030-07
  • Packager: Universal Distribution Center 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 October 7, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (by volume):

    Isopropyl alcohol (99% conc.)

  • PURPOSE

    Purpose

    First aid antiseptic

  • INDICATIONS & USAGE

    Uses

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

    Warnings

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

    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 and all drugs out of the reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    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

    Inactive Ingredient Purified Water

  • SPL UNCLASSIFIED SECTION

    FIRST AID ANTISEPTIC

    For Rubbing & Massaging

    Use only in a well ventilated area:

    Fumes may be harmful.

    WARNING FLAMMABLE!

    Keep away from fire or flame!

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

    Made in India

    Distributed by: Universal Distribution Center

    96 Distribution Boulevard • Edison, NJ 08817

  • Packaging

    label

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 99% 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL99 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-030-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2016
    2NDC:52000-030-02177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2016
    3NDC:52000-030-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2016
    4NDC:52000-030-04296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2016
    5NDC:52000-030-05355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2016
    6NDC:52000-030-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2016
    7NDC:52000-030-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/04/2016
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-030)
    Establishment
    NameAddressID/FEIBusiness Operations
    NOWREZ & ISMAIL SHUKRI COMPANY534665497manufacture(52000-030)
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