Label: LANTISEPTIC DRY SKIN THERAPY- lanolin cream

  • NDC Code(s): 12090-0016-1, 12090-0016-2, 12090-0016-3
  • 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 37%

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  • Purpose

    Skin Protectant

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  • Uses

    • Helps protect ulcer prone skin.
    • For treatment of cracked skin, minor burns or irritation.
    • Helps prevent chafing and dryness.
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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.
    • Massage liberally into affected area as needed.
    • Cover treated feet.
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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

    TC_113.jpgTC 113g image

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  • INGREDIENTS AND APPEARANCE
    LANTISEPTIC  DRY SKIN THERAPY
    lanolin cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:12090-0016
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANOLIN (LANOLIN) LANOLIN 370 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:12090-0016-2 14.2 g in 1 PACKET
    2 NDC:12090-0016-1 113 g in 1 TUBE
    3 NDC:12090-0016-3 227 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(12090-0016)
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