Label: PERSONAL CARE CREAMY PETROLEUM JELLY- petrolatum cream

  • 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 25, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Petrolatum 30%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    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

  • WHEN USING

    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.

  • DO NOT USE

    Do not use on deep puncture wounds, animal bites, serious burns.

  • 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), mineral oil, glycerin, cetearyl alcohol, cetyl alcohol, stearyl alcohol, glyceryl monostearate, petrolatum, fragrance, polysorbate 80, peregal O, butylated hydroxytoluene, methylparaben, propylparaben, dimethyl silicone oil, tocoopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    Personal Care

    Creamy Petroleum Jelly

    Vitamin E Enriched

    Skin Protectant



    For dry skin absorbs quickly

    Compare to the active ingredient of vaseline petroleum jelly cream

    net wt. 4.5oz (128g)



    This product is not manufactured or distributed by unliver, the distributor of the registered trademark Vasoline


    Distributed by:

    Personal Care Products, Inc.

    Bingham Farms, MI 48025-2463 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    Creamy Petroleum jelly

  • PRINCIPAL DISPLAY PANEL

    Creamy Petroleum Jelly

  • INGREDIENTS AND APPEARANCE
    PERSONAL CARE CREAMY PETROLEUM JELLY  
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-0864
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-0864-4128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/07/2011
    Labeler - PERSONAL CARE PRODUCTS, LLC (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chem products Co Ltd530766098manufacture
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