Label: ISOPROPYL ALCOHOL 70 PERCENT- isopropyl alcohol liquid

  • 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 August 1, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Isopropyl alcohol (70% 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
    • if taken internally serious gastric disturbances will result
  • Ask a doctor before use if you have

    • deep puncture 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
    • do not use otherwise than directed
  • Stop use and ask a doctor if

    • condition persists or gets worse
  • Keep out of reach of children.

    In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

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

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • Inactive ingredients

    purified water

    DISTRIBUTED BY:
    Marlex Pharmaceuticals, Inc.
    New Castle, DE 19720
    Made in USA

  • Principal Display Panel

    70% Isopropyl Alcohol
    First Aid Antiseptic
    Helps prevent the risk of infection in minor, cuts, scrapes and burns.
    FL OZ (mL)
    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY FOIL UNDER THE CAP IS BROKEN OR MISSING.

    Principal Display Panel 70% Isopropyl Alcohol First Aid Antiseptic Helps prevent the risk of infection in minor, cuts, scrapes and burns. FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY FOIL UNDER THE CAP IS BROKEN OR MISSING.

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 70 PERCENT 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-106-08473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:10135-106-183785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A08/01/2015
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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