Label: ROYAL PETROLEUM (VITAMIN E ENRICHED)- petrolatum 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 February 19, 2014

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  • SPL UNCLASSIFIED SECTION

    Creamy petroleum Jelly is specially formulated to moisturize, soften and soothe 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

    DRUG FACTS  

    Active Ingredient                                     Purpose

    Petrolatum 30%                                      Skin Protectant

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Temporarily protects minor: cuts  scrapes  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 puncture wounds.

  • WHEN USING

    When using this product, do not get into eyes

  • STOP USE

    Stop use and ask doctor if condition worsens, Symptoms last more than 7 days 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 a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: apply as needed

  • INACTIVE INGREDIENT

    Inactive ingredients:

    water (Aqua),  Carbopol 940, Stearic Acid, Glyceryl Monostearate, Mineral Oil, Cetearyl Alcohol, GE125 Emulsifying Agent, Methylparaben, Propyparaben, Triethanolamine, Tocopheryl Acetate, Cocoa Butter, Fragrance.

  • SPL UNCLASSIFIED SECTION

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

    MADE IN CHINA

    DISTRIBUTED BY:
    Filo America

    P.O. Box 23592

    Los Angeles, CA 90023

    Questions or Concerns?

    1.866.460.0322

  • PRINCIPAL DISPLAY PANEL

    vitamin e enriched

  • INGREDIENTS AND APPEARANCE
    ROYAL PETROLEUM (VITAMIN E ENRICHED) 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-401
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-401-01198 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/19/2014
    Labeler - Filo America (943873703)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.529047265manufacture(50438-401)
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