Label: ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol solution

  • NDC Code(s): 0404-0002-01, 0404-0002-16, 0404-0002-32
  • Packager: Henry Schein Inc.
  • 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 November 12, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 70% v/v

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Flammable

    • keep away from fire or flame, heat, spark, electrical. Flash point 72°F
    • do not use with electrocautery procedures.

    Ask a doctor before use if you have deep or 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 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • the condition persists or gets worse

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • clean infected area
    • apply 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
  • 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

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    Item # 112-7011
    NDC 0404-0002-32

    HENRY SCHEIN®

    70% Isopropyl
    Rubbing Alcohol

    FIRST AID ANTISEPTICTamper evident cap for your protection. If ring-band
    is detached from cap or missing do not use.

    WARNING: Flammable

    (manufacturer)

    Distributed by (in US Only):

    HENRY SCHEIN INC.
    135 Duryea Road
    Melville, NY 11747 USA

    Rev Date: 05/14

    Made in the USA

    32 FL OZ • 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0002-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2014
    2NDC:0404-0002-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2014
    3NDC:0404-0002-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/01/2014
    Labeler - Henry Schein Inc. (012430880)