Label: CUREFINI- petrolatum, cod liver oil ointment

  • NDC Code(s): 79974-202-01, 79974-202-02, 79974-202-04, 79974-202-08
  • Packager: Miramar Cosmetic, Inc.
  • 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 June 12, 2022

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  • Drug Facts:

  • Active Ingredients:

    Petrolatum 30.00%
    Cod Liver Oil 10.00% 

  • Purpose:

    Skin Protectant

  • Uses:

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

  • Warnings:

    • For external use only. • When using this product, do not get into eyes. • If condition worsens or does not improve for seven days, discontinue use and consult a physician.
    • DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN.

    Keep out of reach of children. If swallowed, contact physician or poison control center immediately. Other Information: Store at room temperature.

  • Other Information:

    Store at room temperature.

  • Directions:

    Apply as needed. Prepare a gauze bandage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with a 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.

  • Inactive Ingredients:

    Beeswax, BHT, Chamomilla Recutita (Chamomile) Oil, Helianthus Annuus (Sunflower) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil.

  • SPL UNCLASSIFIED SECTION

    PROPERTIES: CUREFINI is an ointment made with various well known vegetable and animal materials commonly found in the pharmacopeia. When they are combined together in certain proportions, the resulting compound has strong skin protection properties. CUREFINI has been found to provide therapeutic benefits in the treatment for diverse lesions of the skin, and helps restore the skin to its normal, healthy condition. Made of natural substances, CUREFINI does not contain corticoids or antibiotics. CUREFINI is used in a clinical environment to treat burns and wounds, and is also used as a household first-aid product to treat cuts, burns and scrapes.

    Dermal Ointment for Skin Injuries, Cuts, Scrapes and Burns

    ACCEPTED NATIONALECZEMA.ORG

    NATIONAL ECZEMA ASSOCIATION

    Clinically Tested • Pediatrician Tested

    Manufactured for: REV PHARMA CORP, 153 SW 22" Road, MIAMI, FL 33129, US Patent #10016466B2
    Manufactured by: Miramar Lab 2301 NW 107th Ave, Ste 101 Doral, FL 33172, USA
    *Color may vary due to organic yellow beeswax

  • Packaging

    curefiniointment

  • INGREDIENTS AND APPEARANCE
    CUREFINI 
    petrolatum, cod liver oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79974-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM300 mg  in 1 mL
    COD LIVER OIL (UNII: BBL281NWFG) (COD LIVER OIL - UNII:BBL281NWFG) COD LIVER OIL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79974-202-0130 mL in 1 JAR; Type 0: Not a Combination Product06/01/2022
    2NDC:79974-202-0260 mL in 1 JAR; Type 0: Not a Combination Product06/01/2022
    3NDC:79974-202-04120 mL in 1 JAR; Type 0: Not a Combination Product06/01/2022
    4NDC:79974-202-08240 mL in 1 JAR; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2022
    Labeler - Miramar Cosmetic, Inc. (012873243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miramar Cosmetic, Inc.012873243manufacture(79974-202)
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