Label: SOF SKIN PURE PETROLEUM COCOA BUTTER SCENTED- petrolatum jelly

  • NDC Code(s): 76436-130-06, 76436-130-08
  • Packager: Viny Health and Beauty Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/14

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  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP 99.9 %

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  • PURPOSE

    Purpose

    Skin Protectant.

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  • INDICATIONS & USAGE

    Uses

    • Provide relief to dry skin and lips.
    • Offers soothing protection for minor burns.
    • Provides protection for skin from windburn and chapping.
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  • WARNINGS

    Warnings

    For external use only.

    • Do not use on over deep or puncture wounds, infections or lacerations.
    • If redness or swelling develops, consult a physician proply.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

    • Children if swallowed get medical help or contact Poison Control Center right away.
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  • DOSAGE & ADMINISTRATION

    Directions

    Apply product as needed.

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Fragrance

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  • STOP USE

    Stop use and ask doctor if

    • Condition worsen.
    • Symptoms lasts more than 7 days or clean up and occur again.
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  • INGREDIENTS AND APPEARANCE
    SOF SKIN PURE PETROLEUM COCOA BUTTER SCENTED 
    petrolatum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76436-130
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 99.9 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76436-130-08 226 g in 1 JAR
    2 NDC:76436-130-06 170 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/27/2007
    Labeler - Viny Health and Beauty Inc (963374942)
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