Label: CREAMY PETROLEUM- white 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 August 29, 2017

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  • Active ingredient

    White Petrolatum, USP 30%

  • Purpose

    Skin Protectant

  • 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 for this product

    For external use only

  • When using this product

    do not get into eyes.

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up again within a few days
  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply as needed

  • Inactive ingredients

    water, aluminum starch octenylsuccinate, C12-15 alkyl benzoate, myristyl myristate, cetearyl alcohol, glycerin, microcrystalline wax, ceteareth-20, triethanolamine, carbomer, methylparaben, DMDM hydantoin, ethylene brassylate, disodium EDTA, tocopheryl acetate (vitamin E acetate).

  • disclaimer

    This product is not manufactured or distributed by Unilever, distributor of Vaseline Petroleum Jelly Cream

  • Adverse Reactions

    DISTRIBUTED BY:

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

    Quality guaranteed or your money back

    179.000/179.AB

  • principal display panel

    Compare to Vaseline

    Petroleum Jelly Cream

    Cottontails

    baby care

    creamy

    petroleum

    jelly

    skin protectant

    moistruizes & protects

    fragrance-free

    vitamin E enriched

    NET WT 4.5 OZ (127g)

    image description

  • INGREDIENTS AND APPEARANCE
    CREAMY PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM .30 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-003-87127 g in 1 TUBE; Type 0: Not a Combination Product01/29/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/29/2009
    Labeler - Foodhold USA, LLC (809183973)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(41520-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Blending809226710manufacture(41520-003)
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