LABISAN COLD SORE (COLD SORE CARE) OINTMENT [LUPUCA PHARMA GMBH]

LABISAN COLD SORE (COLD SORE CARE) OINTMENT [LUPUCA PHARMA GMBH]
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NDC 72941-932-72
Set ID 83828dc6-a801-6f41-e053-2991aa0a524b
Category HUMAN OTC DRUG LABEL
Packager Lupuca Pharma GmbH
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredients

    Active Ingredients

    Zinc Oxide 20.00%......................................

    Phenol 1.40%.....................

  • Inactive Ingredients

    Inactive ingredients: castor oil, ferric oxide red, ferric oxide yellow, olive oil, paraffin, talcum, vaseline.

  • 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.

    Stop using and consult a physician if the condition persists or gets worse. Do not use longer than

    2 weeks unless directed by a physician.

  • 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.

    Stop using and consult a physician if the condition persists or gets worse. Do not use longer than

    2 weeks unless directed by a physician.

  • Directions

    Directions

    Clean the affected area at first sign of tingling, burning sensation, or itching.
    Apply a small amount of this product to the lips or 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.
    Keep out of reach of children.
    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
    Full UVA and UVB (Broad Spectrum) Sunburn Prevention.

  • 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 Physician 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 and Usage

    Uses

    For treatment of cold sores/fever blisters on the lips 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 outbreak (tingle, or burning sensation).

    ________________________________________________________________________________

    Other information: Store at room temperature.

    Do not get in eyes. Use only as directed.

  • Spanish Version of insert.

    Drug Facts


    Ingredientes activos y propósito:
    Óxido de cinc 20.00% ...... Tratamiento de ampollas febril / úlceras bucales / primeros auxilios / protector solar
    Phenol 1.40% .............. Tratamiento de ampolla febril / antiséptico de primeros auxilios
    __________________________________________________________________________

    Usos
    • Para el tratamiento del herpes labial / ampollas en los labios o la nariz.
    • Alivia temporalmente los síntomas de picazón y dolor asociado con el herpes labial / ampollas febriles.
    • Previene el brote de herpes labial / ampolla febril si se aplica al primer indicio de un brote (cosquilleo o sensación de ardor).
    __________________________________________________________________________

    Advertencias
    Solo para uso externo: no usar en los ojos ni aplicar sobre grandes áreas del cuerpo.
    En caso de heridas profundas o punzantes, mordeduras de animales o quemaduras graves, consulte a un médico.
    __________________________________________________________________________

    Alerta de alergia: No use este producto si es alérgico o hipersensible a cualquiera de los ingredientes de este producto.
    __________________________________________________________________________

    Al usar este producto: No entrar en los ojos. Utilizar sólo según las indicaciones.
    __________________________________________________________________________

    Deje de usar y consulte a un médico si la condición persiste o empeora. No lo use por más de 2 semanas a menos que lo indique un médico.
    __________________________________________________________________________

    Mantener fuera del alcance de los niños. En caso de ingestión, obtenga ayuda médica o comuníquese con un Centro de control de intoxicaciones de inmediato al 1-800-222-1222.
    __________________________________________________________________________

    Direcciones
    • Limpie el área afectada a la primera señal de hormigueo, sensación de ardor o picazón.
    • Aplique una pequeña cantidad de este producto en los labios o la nariz antes de exponerse al sol.
    • En caso de dolor, herpes labial, fiebre, aplique en el área de la sensación.
    • Aplicar hasta 4 veces al día, y por la noche.
    • Frote suavemente.
    • Lavarse las manos antes y después de aplicar la crema.
    • No compartir el producto con nadie.
    • Mantener fuera del alcance de los niños.
    • Niños menores de 12 años: consultar a un médico.
    ________________________________________________________________________________

    Otra información: Almacenar a temperatura ambiente.
    __________________________________________________________________________Ingredientes inactivos: talco, vaselina, , parafina, oleum olivae, oleum ricini, óxido de hierro amarillo y rojo (color).
    __________________________________________________________________________

    ¿Preguntas o comentarios?
    Envíenos un correo electrónico a LabisanAmericas@gmail.com
    Los efectos secundarios graves asociados con el uso de este producto pueden informarse a esta dirección de correo electrónico.
    Si no está completamente satisfecho con nuestro producto, envíe por correo una copia del recibo y el producto restante a la dirección que figura a continuación y llámenos al 1800 Labisan (522-4726).
    Distribuido para Lupuca Pharma GmbH por Labisan Americas, LLC. Norwalk, CT 06851. Hecho en Austria.
    LOT221417 A Artículo # 71625 CAD 11/2019
    Labisan es una marca registrada de Lupuca Pharma Gmbh., Y Labisan Americas, LLC.
    Todas las marcas comerciales y derechos de autor son propiedad de Lupuca Pharma GmbH. y licenciado a Labisan Americas, LLC., grupo de empresas.

    Distribuido para Lupuca Pharma GmbH., Por su Distribuidor Autorizado Exclusivo, Labisan Americas, LLC. (EE. UU., Canadá, Centro y Sudamérica), Norwalk, Connecticut 06851, Hecho en Austria desde 1931.

    Si tiene interés en llevar alguno de nuestros productos Labisan Lip Care, contáctenos en LabisanAmericas@gmail.com, Attn .: New Sales.

  • Use Topical

    Uses

    For treatment of cold sores/fever blisters on the lips 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 outbreak (tingle, or burning sensation).

    Package Back

  • Pricipal display panel

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    LABISAN COLD SORE 
    cold sore care ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72941-932
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    TALC (UNII: 7SEV7J4R1U)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Colorred (dusky pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72941-932-726.7 g in 1 TUBE; Type 0: Not a Combination Product03/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/07/2019
    Labeler - Lupuca Pharma GmbH (301826819)
    Registrant - Lupuca Pharma GmbH (301826819)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lupuca Pharma GmbH301826819manufacture(72941-932) , pack(72941-932) , label(72941-932)

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