Label: CUREFINI - petrolatum and cod liver oil ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/13

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  • CUREFINI Dermal Ointment for cuts & burns SKIN PROTECTION OINTMENT
  • Active Ingredients

    • Petrolatum 30.00%
    • Cod Liver Oil 10.00%
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  • Purpose

    Skin Protectant

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  • Use For:

    • Temporarily protects minor cuts, scrapes and burns.
    • Temporarily protects chapped or cracked skin.
    • Helps protect from drying effects of wind and cold weather. 
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  • Warnings

    • For external use only
    • When using this product, do not get into eyes
    • If conditions worsens or does not improve for seven days, discontinue use and consult a physician
    • Do not use if tamper evident seal is broken
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  • Keep out of reach of children.

    • If swallowed, contact physician or poison control center immediately.
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  • STORAGE AND HANDLING

    Store at room temperature.

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  • Directions:

    • Apply as needed. Prepare a gauze bandage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with spatula, covering the entire surface with a thin layer. Place bandage directly on top of affected area. Make sure affected area remains covered by ointment. 
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  • Other Ingredients:

    beeswax, BHT, Sunflower oil, Sweet almond oil

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  • CUREFINI 8oz/240ml (65121-712-65)
  • INGREDIENTS AND APPEARANCE
    CUREFINI  
    petrolatum, cod liver oil ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65121-712
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 300 mg  in 1 mL
    COD LIVER OIL (COD LIVER OIL) COD LIVER OIL 100 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    BUTYLATED HYDROXYTOLUENE  
    SUNFLOWER OIL  
    ALMOND OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65121-712-65 240 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 01/17/2013
    Labeler - Pure Source (969241041)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source 969241041 manufacture(65121-712)
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