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 January 7, 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), carbopol 940, Stearic Acid, Glyceryl Monostearte, Mineral Oil, Cetearyl Alcohol, GE125 Emulsivying Agent, Methylparaben, Propylparaben, Triethanolamine, Tocopheryl Acetate, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Personal Care

    Creamy Petroleum Jelly

    Vitamin E Enriched

    Skin Protectant



    For dry skin absorbs quickly



    Personal Care 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. Great for moisturizing face and neck.

    Distributed by:

    Personal Care Products, Inc.

    Bingham Farms, MI 48025-2463 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    Creamy Petroleum jelly 7oz

  • 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:29500-2113
    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)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2113-7198 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)
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