Label: ASSURED CREAMY PETROLEUM JELLY VITAMIN E ENRICHED - petrolatum cream 

  • Label RSS
  • NDC Code(s): 33992-1210-1, 33992-1210-2
  • Packager: GREENBRIER INTERNATIONAL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CREAMY

    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.

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  • ACTIVE INGREDIENT

    DRUG FACTS  

    Active Ingredient                                 Purpose

    Petrolatum 30%                                      Skin Protectant

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  • PURPOSE

    Purpose

    Skin Protectant

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  • 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

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  • WARNINGS

    Warnings

    For external use only. Do not use on deep puncture wounds, animal bites and serious burns.

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  • WHEN USING

    When using this product, do not get into eyes

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  • 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.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions: apply as needed

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  • INACTIVE INGREDIENT

    Inactive ingredients:

    water, carbomer, stearic acid, glyceryl stearate, mineral oil, cetearyl alcohol, sodium lauryl sulfate, methylparaben, propylparaben, triethanolamine, tocopheryl acetate, fragrance.

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  • 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


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  • PRINCIPAL DISPLAY PANEL

    CREAMY

    PETROLEUM JELLY

    VITAMIN E ENRICHED



    Skin Softener

    For Dry Skin

    Absorbs Quickly



    Net Wt. 4.5oz (127g)

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  • INGREDIENTS AND APPEARANCE
    ASSURED CREAMY PETROLEUM JELLY VITAMIN E ENRICHED 
    petrolatum cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-1210
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 30 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    STEARIC ACID  
    GLYCERYL MONOSTEARATE  
    MINERAL OIL  
    CETOSTEARYL ALCOHOL  
    SODIUM LAURYL SULFATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-1210-1 127 g in 1 TUBE
    2 NDC:33992-1210-2 198 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 04/25/2013
    Labeler - GREENBRIER INTERNATIONAL (610322518)
    Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
    Establishment
    Name Address ID/FEI Business Operations
    NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265 manufacture(33992-1210)
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