Label: ASSURED CREAMY COCOA BUTTER PETROLEUM VITAMIN E ENRICHED- petrolatum jelly

  • Category: HUMAN OTC DRUG LABEL

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 April 25, 2013

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  • SPL UNCLASSIFIED SECTION

    PETROLEUM JELLY

    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.

  • 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, animal bites and serious burns.

  • 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,Yellow 5, Yellow 6, Red 33, Blue 1.

  • SPL UNCLASSIFIED SECTION

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

    DISTRIBUTED BY:

    GREENBRIER INTERNATIONAL, INC

    CHESAPEAKE VA 23320

    MADE IN CHINA


  • PRINCIPAL DISPLAY PANEL

    CocoaButterPJ

  • INGREDIENTS AND APPEARANCE
    ASSURED CREAMY COCOA BUTTER PETROLEUM VITAMIN E ENRICHED 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1310
    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)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1310-1127 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/25/2013
    Labeler - GREENBRIER INTERNATIONAL (610322518)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.529047265manufacture(33992-1310)
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