Label: CUREFINI SKIN PROTECTION CREAM- petrolatum cream

  • NDC Code(s): 69981-194-01, 69981-194-02, 69981-194-04, 69981-194-08
  • Packager: Rev Pharma Corp
  • 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 30, 2021

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  • Drug Facts:

  • Active Ingredient:

    Petrolatum 30.00%

    Porpose:

    Skin Protectant

  • Uses:

    • For the 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 a 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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  • Package Labeling:30ml

    Label

  • Package Labeling:60ml

    Label2

  • Package Labeling:120ml

    Label3

  • Package Labeling:240ml

    Label4

  • INGREDIENTS AND APPEARANCE
    CUREFINI SKIN PROTECTION CREAM 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69981-194
    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)  
    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:69981-194-0130 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
    2NDC:69981-194-0260 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
    3NDC:69981-194-04120 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
    4NDC:69981-194-08240 mL in 1 JAR; Type 0: Not a Combination Product07/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/12/2021
    Labeler - Rev Pharma Corp (079422405)