Label: CUREFINI- petrolatum cream

  • NDC Code(s): 79974-203-02, 79974-203-04, 79974-203-06
  • Packager: Miramar Cosmetics, Inc DBA Miramar Lab
  • 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 April 24, 2023

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  • DRUG FACTS:

  • Active Ingredient:

    Petrolatum.............30.00%

  • Purpose

    Skin Protectant

  • USES:

    • For temporary protection of minor cuts, scrapes and burns.
    • For temporary protection of cracked and chapped skin.
    • Helps protect from the drying effects of wind and cold weather.

  • WARNINGS: 

    For external use only

    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    • Keep out of reach of children. If swallowed, consult physician.

    • Do not use if tamper evident seal is broken.

  • Directions:

    Apply daily over the affected area, with soft massages to ease absorption. Repeat application as many times as needed to keep skin permanently moisturized.

  • Other information:

    • Store at room temperature.
    • Do not use if tamper evident seal is broken.

  • Inactive Ingredients:

    Aqua (Deionized Water), Beeswax, Cetearyl Alcohol, Cetearyl Olivate, Cetearyl Glucoside, Chamomilla Recutitta (Chamomile) Extract, Chamomilla Recutitta (Chamomile) Oil, Cocamidopropyl Betaine, Ethylhexylglycerin, Gadi Lecur (Cod Liver) Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E).

  • Questions?

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  • SPL UNCLASSIFIED SECTION

    Dermal Cream for cuts & burns

    ACCEPTED NATIONALECZEMA.ORG

    NATIONAL ECZEMA ASSOCIATION

    PROPERTIES: CUREFINI CREAM has been specially developed for the needs of sensitive skin. Contains a delicate combination of petrolatum and fat acids of vegetal origin.

    Manufactured for: REV PHARMA Corp.
    153 SW 22nd Road, MIAMI, FL 33129
    (1786) 574-0011
    US Patent #10.016.466 B1

  • Packaging

    cream203

  • INGREDIENTS AND APPEARANCE
    CUREFINI 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79974-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM300 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79974-203-0259.147 mL in 1 TUBE; Type 0: Not a Combination Product04/24/2023
    2NDC:79974-203-04118.294 mL in 1 TUBE; Type 0: Not a Combination Product04/24/2023
    3NDC:79974-203-06177.441 mL in 1 TUBE; Type 0: Not a Combination Product04/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/24/2023
    Labeler - Miramar Cosmetics, Inc DBA Miramar Lab (012873243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miramar Cosmetics, Inc DBA Miramar Lab012873243manufacture(79974-203)
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