Label: LANTISEPTIC DRY SKIN THERAPY- lanolin cream

  • NDC Code(s): 12090-0016-1, 12090-0016-2
  • Packager: Santus LLC
  • 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 4, 2016

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

  • Drug Facts
  • Active Ingredient

    Lanolin USP 30%

    Purpose

    Skin Protectant

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  • Uses

    • Helps protect ulcer prone skin. • For treatment of cracked skin, minor burns or irritations. • 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.

    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 15-30°C (59-86°F)

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  • Inactive Ingredients

    Beeswax (Yellow Wax), Disodium EDTA, DMDM Hydantoin + IPBC, Lanolin Alcohol, Mineral Oil, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate.

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  • Questions or Comments?

    844-7SANTUS or visit www.lantiseptic.com

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    LANTISEPTIC DRY SKIN THERAPY 
    lanolin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:12090-0016
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 300 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12090-0016-2 14.2 g in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:12090-0016-1 113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/02/2016
    Labeler - Santus LLC (079868223)
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