LABISAN (COLD SORE CARE) OINTMENT [LABISAN AMERICAS, LLC.]

LABISAN (COLD SORE CARE) OINTMENT [LABISAN AMERICAS, LLC.]
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NDC 72892-932-72
Set ID 81787b60-bd34-67a3-e053-2a91aa0abc75
Category HUMAN OTC DRUG LABEL
Packager Labisan Americas, LLC.
Generic Name
Product Class
Product Number
Application Number PART347
  • Active ingredients

    _________________________________________________________________

    Active Ingredients Purpose

    Zinc Oxide 20.00%................................................................Cold sore/fever blister treatment/first aid/ sun protectant

    Phenol 4.00%........................................................................Cold sore/fever blister treatment/first aid antiseptic

    Sulfur Praecipitotum 10.00%.................................................Cold sore/fever blister treatment/first aid antiseptic

    ___________________________________________________________________________________________

  • Inactive Ingredients

    nactive ingredients Talcum, vaseline, shea butter, paraffin, Olive oil, castor oil, iron oxide yellow and red (for color).

    ___________________________

  • Keep out of reach Children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

    ______________

  • Stop using and consult a doctor if the condition persists or gets worse. Do not use longer than 2 weeks unless directed by a doctor.

  • WARNINGS

    Warnings

    For external use only: Do not use in the eyes, or apply over large areas of the body.

    In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.

  • Directions

    • Directions
    clean the affected area at first sign of tingling, burning sensation, or itching.
    apply a small amount of this products to the lips and nose prior to exposure to the sun.
    in case of cold sore/fever blister indication, apply to area of sensation.
    apply up to 4 times a day, and in the evening.
    rub in gently.
    wash hands before and after applying cream.
    do not share product with anyone.
    children under 12 years of age: consult a Physician

  • Uses

    Uses

    for treatment of cold sores/fever blisters on the lips, face, and/or nose

    temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters

    prevents outbreak of cold sore/fever blister if applied at first indication of an out break (tingle, or burning sensation)

    heals cold sore/fever blisters

    prevents and heals sun burn to lips and stimulates rapid healing

  • Precautions Allergy alert. When using product, Stop and consult Physician,

    Warnings

    For external use only: Do not use in the eyes, or apply over large areas of the body.

    In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.

    ___________________________________________________________________________________________

    Allergy alert: Do not use this product if you are allergic or hypersensitive to any of the ingredients in this product.

    ___________________________________________________________________________________________

    When using this product: Do not get in eyes. Use only as directed.

    ___________________________________________________________________________________________

    Stop using and consult a doctor if the condition persists or gets worse. Do not use longer than 2 weeks unless directed by a doctor.

    ___________________________________________________________________________________________

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • INDICATIONS & USAGE

    Do not get in eyes. Use only as directed.

  • USe Dosage..Topical

  • Pricipal display panel

    PLPDP

  • INGREDIENTS AND APPEARANCE
    LABISAN 
    cold sore care ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72892-932
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72892-932-726.7 mg in 1 TUBE; Type 0: Not a Combination Product02/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/22/2019
    Labeler - Labisan Americas, LLC. (105632604)
    Registrant - Labisan Americas, LLC. (105632604)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lupuca Pharma GmbH.301826819manufacture(72892-932)

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