LANOGUARD DRY SKIN THERAPY (LANOLIN) CREAM [SUMMIT INDUSTRIES, INC.]

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LANOGUARD DRY SKIN THERAPY (LANOLIN) CREAM [SUMMIT INDUSTRIES, INC.]
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NDC 12090-0042-5
Set ID 949fc142-c7ba-4f73-b47a-418e079da3ae
Category HUMAN OTC DRUG LABEL
Packager Summit Industries, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredient

    Lanolin USP 37%

  • Purpose

    Skin Protectant

  • Uses

    • Helps protect ulcer prone skin.
    • For treatment of cracked skin, minor burns or irritation.
    • Helps prevent chafing and dryness.
  • 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.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.

  • Directions

    • ​Gently cleanse and dry area.
    • Massage liberally into affected area as needed.
    • Cover treated feet.
  • Other Information

    Store at 20-25°C (68-77°F)

  • Inactive Ingredients:

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

  • Questions Comments?

    1-800-241-6996 or www.lantiseptic.com

    SUMMIT INDUSTRIES, INC

    Lantiseptic Division

    PO BOX 7329

    Marietta, GA 30065

  • Image of representative artwork

    LanoGuardDrySkinfouroz.jpgLabel

  • INGREDIENTS AND APPEARANCE
    LANOGUARD  DRY SKIN THERAPY
    lanolin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12090-0042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN370 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID (UNII: R79J91U341)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OXYQUINOLINE (UNII: 5UTX5635HP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12090-0042-5113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/30/2009
    Labeler - Summit Industries, Inc. (003279189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Summit Industries, Inc.003279189manufacture(12090-0042)
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