ISOPROPYL ALCOHOL 70 PERCENT (ISOPROPYL ALCOHOL) LIQUID [MARLEX PHARMACEUTICALS INC]

ISOPROPYL ALCOHOL 70 PERCENT (ISOPROPYL ALCOHOL) LIQUID [MARLEX PHARMACEUTICALS INC]
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NDC 10135-106-08, 10135-106-18
Set ID 0cd5ad3d-338e-4df5-892f-8f904687634a
Category HUMAN OTC DRUG LABEL
Packager Marlex Pharmaceuticals Inc
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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)