Label: LANOLIN ointment

  • NDC Code(s): 68786-232-01, 68786-232-02, 68786-232-03, 68786-232-04, view more
    68786-232-05, 68786-232-06
  • Packager: Sion Biotext Medical Ltd
  • 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 January 3, 2022

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  • ACTIVE INGREDIENT

    Active ingredient               Purpose

    Lanolin USP 50%                    Skin Protectant

  • Uses:

    • 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

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


  • Directions:

    • Gently cleanse and dry area
    • Apply liberally to affected area as needed
  • Inactive Ingredient


    Inactive Ingredients: Beeswax, Fragrance, HEEDTA, Lanolin alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified water, Sodium borate, Sesquioleate


  • Keep Out Of Reach Of Children

    Keep Out Of Reach Of Children

  • Principal Display Panel

    Sion Biotext Medical Ltd

    LANTISEPTON OINTMENT

    SKIN BARRIER

    FOR INCONTINENCE DIAPER DERMATITIS, CHAFED OR ULCER PRONE SKIN

    NET WT. 4 oz (113.6 g)

    Label

  • INGREDIENTS AND APPEARANCE
    LANOLIN 
    lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-232
    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:68786-232-012 in 1 CASE07/09/2012
    1144 in 1 BOX
    15 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68786-232-024 in 1 CASE07/09/2012
    236 in 1 BOX
    215 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:68786-232-0336 in 1 CASE07/09/2012
    371 g in 1 JAR; Type 0: Not a Combination Product
    4NDC:68786-232-0424 in 1 CASE07/09/2012
    4114 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:68786-232-0524 in 1 CASE07/09/2012
    571 g in 1 JAR; Type 0: Not a Combination Product
    6NDC:68786-232-0612 in 1 CASE07/09/2012
    6396.8 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/09/2012
    Labeler - Sion Biotext Medical Ltd (532775194)
    Registrant - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(68786-232)