Label: RUBBING ALCOHOL- isopropyl alcohol solution

  • 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 17, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 99% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    For first aid use to decrease germs in minor cuts and scrapes

  • Warnings

    For external use only.
    •If taken internally serious gastric disturbances will result
    • Do not use in or near the eyes
    • In case of deep or puncture wounds, consult your doctor.
    Flammable keep away from heat or flame.
    Use only in a well-ventilated area; fumes may be toxic.
    Ask a doctor before use if you have deep or puncture wounds, animal
    bites or serious burns.

  • WHEN USING

    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 USE

    Stop use and ask a doctor if condition persists or gets worse

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of ingestion, get medical help
    or contact a Poison Control Center immediately.

  • Directions

    • Directions • Clean affected area • Apply a small amount of this product
      1-3 times daily • If bandaged let dry first • May be covered with a sterile
      bandage
  • Other information

    • Other information
      • Store at room temperature
      • Does not contain, nor is intended as a substitute for ethyl alcohol
  • Inactive ingredients

    Inactive Ingredients: Purified Water.

  • Package Label - Principal Display Panel

    3785mL NDC: 74220-006-01

    label

  • INGREDIENTS AND APPEARANCE
    RUBBING ALCOHOL 
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74220-006
    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:74220-006-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2020
    Labeler - Super Dope Laboratories LLC (055650002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Super Dope Laboratories LLC055650002manufacture(74220-006) , label(74220-006)
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