Active Ingredients
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Active Ingredients
Zinc Oxide 20.00%......................................
Phenol 1.40%.....................
Labisan
FDA Label NDC 72892-932
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Labisan Americas, Llc. for the product Labisan (NDC 72892-932). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, keep out of reach children, 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, directions, uses, precautions allergy alert. when using product, stop and consult physician,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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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)
- Prevents and heals sun burn to lips and stimulates rapid healing
- Full UVA and UVB (Broad Spectrum) Sunburn Prevention.
heals cold sore/fever blisters.
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.
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Allergy alert: Do not use this product if you are allergic or hypersensitive to any of the ingredients in this product.
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When using this product: Do not get in eyes. Use only as directed.
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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.
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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
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).
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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
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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).
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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.
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Alerta de alergia: No use este producto si es alérgico o hipersensible a cualquiera de los ingredientes de este producto.
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Al usar este producto: No entrar en los ojos. Utilizar sólo según las indicaciones.
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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.
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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.
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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.
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Otra información: Almacenar a temperatura ambiente.
__________________________________________________________________________Ingredientes inactivos: talco, vaselina, , parafina, oleum olivae, oleum ricini, óxido de hierro amarillo y rojo (color).
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¿Preguntas o comentarios?
Envíenos un correo electrónico a [email protected]
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 [email protected], 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).
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