Label: LUXURY ANTISEPTIC- 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 March 10, 2021

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  • Active ingredient

    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 

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

    Ask a doctor before use if you have deep 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
  • Inactive ingredient

    purified water

  • Principal Display Panel

    3

  • INGREDIENTS AND APPEARANCE
    LUXURY  ANTISEPTIC
    isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-024
    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:76772-024-47473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/10/2021
    Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
    Establishment
    NameAddressID/FEIBusiness Operations
    TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-024)
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