Label: ASPICARE- isopropyl rubbing 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 March 8, 2021

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  • Active Ingredient

    Isopropyl Alcohol 70% v/v.

  • Purpose

    First Aid Antiseptic

  • Use

    helps prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Flammable • Keep away from fire or flame, heat, spark, or electrical

    Ask a doctor before use

    or deep or puncture wounds, animal bites or serious burns

    When using this product

    do not get into eyes • do not inhale • do not apply over large areas of the body • do not use longer than 1 week

    Stop use and ask a doctor if

    condition persists or gets worse

    Keep out of reach of children

    f swallowed, get medical help or contact a Poison Control Center right away.

  • Caution

    Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

  • Directions

    Clean the affected area • apply a 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

  • Storage

    • Store below 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water (Aqua)

  • Other Information

    Does not contain, nor is intended as a substitute for grain or ethyl alcohol • will produce serious gastric disturbances if taken internally.

  • Principal Display Panel

    NDC 70735-072-08, 70735-072-16, 70735-072-32, 70735-072-28

    Isopropyl Rubbing Alcohol 70%

    FIRST AID ANTISEPTIC

    WARNING FLAMMABLE

    Keep away from heat, spark, electrical, fire or flame

    Use only in a well-ventilated area; fumes may be harmful.

    Caution: Do not point at self or others; Product will squirt when squeezed.

    8 FL OZ (236 mL)

    16 FL OZ (473 mL)

    32 FL OZ (946 mL) 1 Litre

    128 FL OZ (3785 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    ASPICARE 
    isopropyl rubbing alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70735-072
    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:70735-072-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2021
    2NDC:70735-072-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2021
    3NDC:70735-072-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2021
    4NDC:70735-072-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/08/2021
    Labeler - American Private Label Products (051667474)
    Registrant - American Private Label Products (051667474)
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