Label: ISOPROPYL ALCOHOL liquid

  • NDC Code(s): 68016-845-43
  • Packager: Pharmacy Value Alliance, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 28, 2022

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

  • Active ingredients

    Isopropyl alcohol 70%

  • Purpose

    First aid antiseptic

  • Use

    helps prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only. If takes internaly serious gastric disturbances will result.

  • Flammable

    • keep away from fire or flame, heat, spark, electrical
  • 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 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

    If 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 gettting 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
  • Other information

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
    • will product serious gastric disturbances if taken internally
  • Inactive ingredients

    blue 1, glycerin, methyl salicylate, water, yellow 5

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancater Avenue,

    Wayne, PA 19087

  • principal display panel

    Premier

    Value

    70%

    Isopropyl

    Alcohol

    with wintergreen & glycerin

    first aid antiseptic

    square bottle used less plastic than a simillarly sized round bottle.

    Recyclabel ( if availabe in your area)

    Warning Flammable -Keep awau from heat, spark, electrical, fire and 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.

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-845
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL613 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-845-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34405/14/2009
    Labeler - Pharmacy Value Alliance, LLC (101668460)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(68016-845)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(68016-845)