Label: PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid

  • 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 December 7, 2020

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

  • EXTRA INFORMATION ON FRONT LABEL :

    • FIRST AID AND ANTISEPTIC: Helps prevent the risk of infection in minor cuts, scrapes and burns
    • WARNING :Flammable,keep away from heat ,spark ,electrical fire or flame : Use only in well ventilated area .Fumes may be harmful
    • CAUTION : Do not point at self or others, product will squirt when squeezed
  • Active Ingredients

    Isopropyl Alcohol 70%

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent the risk of infection in

    • Minor cuts
    • Scrapes
    • Burns
  • Warnings

    For external use only

    • If taken internally serious gastric disturbances will result.

    Flammable : keep away from fire or flame ,heat, spark ,electrical.

    Ask a doctor before use for 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 area of the body ,do not use longer than 1 week.

    Stop use and ask a doctor if condition persist or get 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 getting into eyes or mucus membranes .Avoid inhaling this product.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Clean the affected area.
    • Apply a small amount of this product on the area 1 to 2 times daily.
    • May be covered with a sterile bandage.
    • If bandaged lets dry first.
  • Other Information

    • Does not contain ,nor is intended as a substitute for grain or ethyl alcohol.
    • Tamper Evident : Do not use if the under cap safety foil is broken or missing.
  • Inactive ingredients

    • Water ( Aqua)
    • Methyl Salicylate
    • Laneth -75
    • FD and C Blue #1
    • FD AND C YELLOW #5
  • Product Image

    image description

  • INGREDIENTS AND APPEARANCE
    PHARMACY PRESCRIPTION 70% ISOPROPYL ALCOHOL WITH WINTERGREEN 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68121-002
    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)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    LANETH-75 (UNII: QQ4C4Q56ST)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68121-002-01354.8 mL in 1 BOTTLE; Type 0: Not a Combination Product12/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/30/2020
    Labeler - PATCOS COSMETICS (INDIA) PRIVATE LIMITED (916169451)
    Establishment
    NameAddressID/FEIBusiness Operations
    PATCOS COSMETICS (INDIA) PRIVATE LIMITED675973979manufacture(68121-002)