Label: ROYAL CREAMY PETROLEUM JELLY- petrolatum jelly jelly

  • 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 15, 2022

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  • 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. Do not use on deep wounds.

    When using this product do not get into eyes.

  • 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 contact Poison Control Center right away.

  • Directions

    Directions: Apply as needed.

  • Inactive Ingredients

    Inactive Ingredients:

    Water (Aqua), Mineral Oil, Stearic Acid, Glyceryl Monostearate, Cetearyl Alcohol, CM 1000, Fragrance, Triethanolamine, Carbopol 940, Methyl Paraben, Propyl Paraben, Sodium Lauryl Sulphate, Vitamin E.

  • SPL UNCLASSIFIED SECTION

    Made in India

    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)

  • 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.

  • Package Label

    Royal Petroleum Jelly

  • INGREDIENTS AND APPEARANCE
    ROYAL CREAMY PETROLEUM JELLY 
    petrolatum jelly jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73597-001
    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
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CETETH-20 (UNII: I835H2IHHX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73597-001-07198 g in 1 TUBE; Type 0: Not a Combination Product02/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/05/2020
    Labeler - Mission Series Inc. dba Prestige Beauty Care (117190866)
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