Label: PETROLEUM JELLY COCOA BUTTER- petrolatum cream

  • 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 October 26, 2020

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  • Active Ingredient

    Petrolatum 30%

  • Purpose

    Skin Protectant

  • Uses

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

    • For external use only.
    • When using this product do not get into eyes.
    • Stop use and ask a doctor if condition worsens,symptoms last more than 7 days or clear up and occur again within a few days.
    • Do not use on deep puncture wounds.If swallowed,get medical help or contact a poison control center right away

    Keep Out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions 

    Apply as needed.

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive ingredients

    Water,Mineral Oil,Stearic Acid,Glyceryl Monostearate,Cetearyl Alcohol,CM 1000,Fragrance,Triethanolamine,Carbopol 940,Methyl Paraben,
    Propyl Paraben,Sodium Lauryl Sulphate,Vitamin E,Cocoa Butter,FD and C Red 40[CI No.16035],FD and C Yellow 5 [CI No .19140].

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    PETROLEUM JELLY COCOA BUTTER 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73398-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73398-113-01128 g in 1 TUBE; Type 0: Not a Combination Product10/17/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/17/2020
    Labeler - SUHAN AEROSOL (861140760)
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