Label: LANOLIN ointment

  • 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 May 22, 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 (Yellow Wax), Fragrance, HEEDTA, Lanolin alcohol, Mineral oil, Oxyguinoline, Petrolatum, Purified water, Sodium borate, Sorbitan sesquioleate

  • Principal Display Panel

    LanolinEnter section text here

  • INGREDIENTS AND APPEARANCE
    LANOLIN 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-232
    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
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OXYQUINOLINE (UNII: 5UTX5635HP)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-232-012 in 1 CASE
    1144 in 1 BOX
    15 g in 1 PACKET
    2NDC:67777-232-024 in 1 CASE
    236 in 1 BOX
    215 g in 1 PACKET
    3NDC:67777-232-0336 in 1 CASE
    371 g in 1 JAR
    4NDC:67777-232-0424 in 1 CASE
    4113 g in 1 TUBE
    5NDC:67777-232-0524 in 1 CASE
    5127.5 g in 1 JAR
    6NDC:67777-232-0612 in 1 CASE
    6396.8 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/12/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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