Label: LANA1263- lanolin ointment

  • Category: HUMAN OTC DRUG LABEL

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 October 23, 2014

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  • ACTIVE INGREDIENT

    Active ingredient               Purpose
    Lanolin USP 50%                    Skin Protectant

  • Purpose:

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

    For External Use Only

  • Keep Out Of Reach Of Children

    KEEP OUT OF REACH OF CHILDREN

    • If swallowed, get medical help or contact a Poison Control Center right away
  • Indications & Usage

    • 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
  • Dosage & Administration

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

    • Store at room temperature 20 deg C to 25 deg C 68 deg F to 77 deg F
  • Inactive Ingredients

    Beeswax (White), EDTA, Emulsifying wax, Lanolin alcohol, Lavender perfume, Mineral oil, Petrolatum, Purified water, Sodium borate

  • Principal Display Panel

    Lana1263 Ointment

    Lana1263.jpg

    Lana1263

  • INGREDIENTS AND APPEARANCE
    LANA1263 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-232-015 g in 1 PACKET
    2NDC:61767-232-0215 g in 1 PACKET
    3NDC:61767-232-0371 g in 1 JAR
    4NDC:61767-232-04113 g in 1 TUBE
    5NDC:61767-232-05127.5 g in 1 JAR
    6NDC:61767-232-06396.8 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/23/2014
    Labeler - Blossom Pharmaceuticals (677381470)
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