Label: ROYAL CREAMY PETROLEUM JELLY COCOA BUTTER- petrolatum jelly jelly

  • NDC Code(s): 73597-014-07
  • Packager: Mission Series Inc. dba Prestige Beauty Care
  • 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 August 11, 2020

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  • SPL UNCLASSIFIED SECTION

    Creamy Petroleum Jelly is specially formulated to moisturize, soften and sooth dry skin. Blended with Vitamin E to produce a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

  • Active Ingredient

    Active Ingredient: Petrolatum 30%

  • Purpose

    Purpose Skin Protectant

  • Indications & Usage

    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

    Warnings:

    For external use only.

    When using this product do not get into eyes.

    Do not use on deep puncture wounds.

  • Stop Use

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children. If swallowed, get medical help or contacit Poison Control Center right away.

  • Directions

    Directions: Apply as needed.

  • Inactive Ingredients

    Inactive Ingredients: Water (Aqua), Mineral Oil, Cetearyl Alcohol, Glyceryl Stearate, Glycerin, Ceteareth-20, Propylene Glycol, Carbomer, Dimethicone, Triethanolamine, Fragrance, Tocopheryl Acetate, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter), Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No. 5, FD&C Red No. 40.

  • SPL UNCLASSIFIED SECTION

    Made in China

    DISTRIBUTED BY:

    PRESTIGE BEAUTY CARE

    1585 West Mission Blvd.

    Pomona, CA 91766

    * This product is not manufactured or distributed by Unilever, distributor of the registered trademark Vaseline (r).

  • PRINCIPAL DISPLAY PANEL

    Petroleum Jelly Cocoa Scent

  • INGREDIENTS AND APPEARANCE
    ROYAL CREAMY PETROLEUM JELLY COCOA BUTTER 
    petrolatum jelly jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73597-014
    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)  
    2,2'-((2-(DODECYLOXY)ETHYL)IMINO)BISETHANOL (UNII: 5MYL465X9V)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73597-014-07198 g in 1 TUBE; Type 0: Not a Combination Product08/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/11/2020
    Labeler - Mission Series Inc. dba Prestige Beauty Care (117190866)
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