Label: LANTISEPTIC SKIN PROTECTANT- lanolin cream 

  • Label RSS
  • NDC Code(s): 12090-0019-1, 12090-0019-2, 12090-0019-3, 12090-0019-4, view more
    12090-0019-5, 12090-0019-6
  • Packager: Summit Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 01/13

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

  • Active Ingredient

    Lanolin USP 50%

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  • Purpose

    Skin Protectant

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  • Uses

    • Helps prevent and treat diaper dermatitis.
    • Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.
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  • Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Do not apply to deep or puncture wounds.
    • If condition worsens, or does not improve within 7 days, consult a doctor.
    • If swallowed, get medical help or contact a Poison Control Center right away.
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  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
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  • Directions

    • Gently cleanse and dry area.
    • Apply liberally to affected area as needed.
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  • Other information

    Store at 20-25°C (68-77°F)

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  • Inactive ingredients

    Beeswax (yellow wax), Fragrance, HEEDTA, Lanolin Alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate

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  • QUESTIONS

    If you have questions or comments, call

    800-241-6996 or visit

    www.Lantiseptic.com

    SUMMIT INDUSTRIES, INC

    Lantiseptic Division

    PO BOX 7329

    Marietta, GA 30065

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  • Image of representative container

    SP400g.jpgSkin Protectant Label 400 grams

    SP_130.jpg image description

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  • INGREDIENTS AND APPEARANCE
    LANTISEPTIC  SKIN PROTECTANT
    lanolin cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:12090-0019
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANOLIN (LANOLIN) LANOLIN 500 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID  
    LANOLIN ALCOHOLS  
    MINERAL OIL  
    OXYQUINOLINE  
    PETROLATUM  
    WATER  
    SODIUM BORATE  
    SORBITAN SESQUIOLEATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12090-0019-6 5 g in 1 PACKET
    2 NDC:12090-0019-1 14.2 g in 1 JAR
    3 NDC:12090-0019-2 70 g in 1 TUBE
    4 NDC:12090-0019-3 113 g in 1 JAR
    5 NDC:12090-0019-4 130 g in 1 JAR
    6 NDC:12090-0019-5 400 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 12/30/2009
    Labeler - Summit Industries, Inc. (003279189)
    Registrant - Summit Industries, Inc. (003279189)
    Establishment
    Name Address ID/FEI Business Operations
    Summit Industries, Inc. 003279189 manufacture(12090-0019)
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