Label: SOF SKIN PURE PETROLEUM- petrolatum jelly

  • NDC Code(s): 76436-128-06, 76436-128-08
  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    White Petrolatum USP 100 %

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  • PURPOSE

    Purpose

    Skin Protectant.

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  • INDICATIONS & USAGE

    Uses

    • For the the temporary protection of minor cuts, scrapes, burns and sunburn.
    • Helps to temporarily protect chafed, chapped , cracked or windburned skin and lips.
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  • WARNINGS

    Warning

    For external use only.

    Do not use on

    • Deep or Puncture Wounds
    • Animal Bites
    • Serious Burns

    When using this product

    • Do not get in to eyes
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  • STOP USE

    Warning

    For external use only.

    Do not use on

    • Deep or Puncture Wounds
    • Animal Bites
    • Serious Burns

    When using this product

    • Do not get in to eyes
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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

    None

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  • INGREDIENTS AND APPEARANCE
    SOF SKIN PURE PETROLEUM 
    petrolatum jelly
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76436-128
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 100 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76436-128-08 226 g in 1 JAR
    2 NDC:76436-128-06 170 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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