Label: LANOGUARD DRY SKIN THERAPY- lanolin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 21, 2013

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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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