Label: FRESKARO DECOLORIZED IODINE- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Freskaro Decolorized Iodine

    Drug Facts

  • Active Ingredient

    Alcohol 48%

  • Purpose

    First Aid Antiseptic

  • Uses

    First Aid Antiseptic to help prevent infection in in minor, cuts, scrapes and burns.

  • Warnings

    For External Use Only

    When using the product

    Do not use in the eyes or apply over large areas of the bosy. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

    Stop use and consult a doctor if

    the condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately. Soap will deactivate the effects of this product.

  • Directions

    • Clean the affected area. Apply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
  • Inactive Ingredient

    Ammonia Hydroxide, Iodine, Potassium Iodide, Purified water.

  • Other information

    Flammable: Keep away from spark, heat and flame

  • PRINCIPAL DISPLAY PANEL

    Freskaro Decolorized 5-16-23

  • INGREDIENTS AND APPEARANCE
    FRESKARO DECOLORIZED IODINE 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82645-207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.48 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    IODINE (UNII: 9679TC07X4)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82645-207-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/16/2023
    Labeler - Pharma Nobis, LLC (118564114)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(82645-207) , manufacture(82645-207) , pack(82645-207) , label(82645-207)
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