NDC 72892-932 Labisan

Cold Sore Care

NDC Product Code 72892-932

NDC Product Information

Labisan with NDC 72892-932 is a a human over the counter drug product labeled by Labisan Americas, Llc.. The generic name of Labisan is cold sore care. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Labisan Americas, Llc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Labisan Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENOL 1.4 mg/100mg
  • ZINC OXIDE 20 mg/100mg

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Labisan Americas, Llc.
Labeler Code: 72892
FDA Application Number: part347 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-22-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Labisan Product Label Images

Labisan Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

_________________________________________________________________Active IngredientsZinc 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

WarningsFor 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 than2 weeks unless directed by a physician.

Directions

  • DirectionsClean 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

  • UsesFor treatment of cold sores/fever blisters on the lips, face, and/or noseTemporarily relieves the symptoms of itching and pain associated with cold sores/fever blistersPrevents 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 healingFull UVA and UVB (Broad Spectrum) Sunburn Prevention.

Precautions Allergy Alert. When Using Product, Stop And Consult Physician,

WarningsFor 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 & Usage

UsesFor 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

UsesFor 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).

* Please review the disclaimer below.

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