Label: EIGHT HOUR CREAM SKIN PROTECTANT- petrolatum lotion

  • 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 14, 2011

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  • DESCRIPTION

    (On Box) Uses: Treats symptoms of: chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions, cracked lips.

    (On Tube) Soothes minor skin irritations. Also for symptoms of chapping, peeling or flaking due to minor burns, sunburn, windburn, scrapes, abrasions or cracked lips.

  • INDICATIONS AND USAGE

    To Use: Apply liberally as often as necessary.

  • WARNINGS

    (On Box) Warnings: For external use only. When using this product: Avoid contact with eyes. Do not apply over puncture wounds, infections, or lacerations. Stop using and ask a doctor if: symptoms persist more than 7 days.

    (On Tube) Warning: For external use only. Avoid contact with eyes. Discontinue use if symptoms persist more than 7 days and consult a physician. Not to be applied over puncture wounds, infections, or lacerations.

  • OTC - ACTIVE INGREDIENT

    Active Ingredient: Petrolatum 56.8%.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Lanolin, Mineral Oil, Tocopherol, BHT, Salicylic Acid, Rincinus Communis (Castor) Seed Oil, Vegetable Oil, Zea Mays (Corn) Oil, Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Propylparaben, Iron Oxides.

  • DOSAGE & ADMINISTRATION

    Apply liberally.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTC - PURPOSE

    Skin protectant.

  • OTC - WHEN USING

    Avoid contact with eyes.

  • PRINCIPAL DISPLAY PANEL

    Eight Hour Cream Skin Protectant Box

    Eight Hour Cream Skin Protectant Tube

  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR CREAM SKIN PROTECTANT 
    petrolatum lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM28.4 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CORN OIL (UNII: 8470G57WFM)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-0105-11 in 1 BOX
    1NDC:67938-0105-250 g in 1 TUBE
    2NDC:67938-0105-31 in 1 BOX
    2NDC:67938-0105-415 g in 1 TUBE
    3NDC:67938-0105-51 in 1 BOX
    3NDC:67938-0105-630 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/03/2009
    Labeler - Elizabeth Arden, Inc (849222187)
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