Label: CREAMY PETROLEUM- white 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 March 1, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    White Petrolatum USP 30%

    Purpose
    skin protectant
  • INDICATIONS & USAGE

    Uses
    •temporarily protects minor: •cuts •scrapes •burns
    •temporarily protect 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 this product do not get into eyes

    Stop use and ask a doctor if •condition worsens •symptoms longer than 7 days or clear up and occur 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.
  • DOSAGE & ADMINISTRATION

    Directions apply as needed
  • INACTIVE INGREDIENT

    Inactive ingredients water, aluminum starch octenylsuccinate,  C12-15 alkyl benzoate, myristyl myristate, cetearyl alcohol, glycerin, microcrystalline wax,  ceteareth-20, triethanolamione, carbomer, methylparaben, DMDM hydantoin, ethylene brassylate, disodium EDTA, tocopheryl acetate (vitamin E acetate)
  • PRINCIPAL DISPLAY PANEL

    DGbody
    Creamy
    Petroleum
    Jelly
    •Skin protectant
    •For dry skin relief
    •Vitamin E enriched
    •Fragrance-free
    Compare to Vaseline Petroleum Jelly Cream
    NEW WT 4.5 oz (127g)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    CREAMY PETROLEUM 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-179
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM .30 g  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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-179-87127 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/05/2009
    Labeler - Dollar General (068331990)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    American Blending809226710manufacture
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