LANOLIN OINTMENT [SION BIOTEXT MEDICAL LTD]

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LANOLIN OINTMENT [SION BIOTEXT MEDICAL LTD]
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NDC 68786-232-01, 68786-232-02, 68786-232-03, 68786-232-04, 68786-232-05, 68786-232-06
Set ID 115af0c8-a6fa-4d8e-9b22-9912d7fbc9ba
Category HUMAN OTC DRUG LABEL
Packager Sion Biotext Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART347
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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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(68786-232)
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