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Producto de salud natural autorizado en Canadá
- Titular
- RGR Pharma Ltd.
- NPN o DIN-HM
- 80089256
- Estado
- Licencia activa
- Fecha de licencia
- 20 de noviembre de 2018
- Fecha de revisión
- No indicada
- Forma
- Crème
- Vía de administración
- Topique
- Tipo de solicitud
- Non traditionnelle
El análisis de dosis orales no se aplica sin una vía exclusivamente oral establecida.
Composición
| Ingrediente medicinal y fuente | Por unidad posológica, según la fuente |
|---|---|
| 1,4-Benzènediol Fuente : Hydroquinone | 2 % |
Ingredientes no medicinales
Sorbate de potassium, Aminopropyl Ascorbyl Phosphate, Béhénate de béhényle, Niacinamide, Lévulinate de sodium, Propanediol, EDTA, Métabisulfite de sodium, Isohexadecane, Quillaja saponaria bark extract, Alcool cétylique, Hydroxide de sodium, Acrylamide/Sodium Acrylodimethyltauratre Copolymer, Boerhavia diffusa Root Extract, Stéarate de PEG-100, BHT, Poly(sorbate) 80, d-alpha tocophérol, Aqua, Stéarate de glycéryle, Saccharide Isomerate, Glycérine
Dosis recomendadas en Canadá
| Población | Edad | Cantidad por toma | Frecuencia |
|---|---|---|---|
Adultos Traducido automáticamente del francés. Ver el originalAdultes | No especificada Traducido automáticamente del francés. Ver el originalNon précisée | Traducción no disponible. Texto original, idioma: francés. 1 Crème | No especificada Traducido automáticamente del francés. Ver el originalNon précisée |
Usos autorizados en Canadá
Traducción no disponible. Texto original, idioma: inglés.
For the gradual lightening of hyperpigmented skin conditions.Un uso autorizado en Canadá no es una declaración de propiedades saludables autorizada en la Unión Europea. Consulte el registro de declaraciones de propiedades saludables.
Advertencias en Canadá
Traducción no disponible. Texto original, idioma: inglés.
Contra-Indications : People with prior history of sensitivity or allergic reactions to this product or any of its ingredients should not use the product. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.Traducción no disponible. Texto original, idioma: inglés.
Known Adverse Reactions : No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately. Contains sodium metabisulfite, a sulfite that may cause severe allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attacks) in susceptible individuals.Traducción no disponible. Texto original, idioma: inglés.
Cautions and Warnings : If you have a family history of, have or have had, or are at risk of developing cancer, do not use. To be used only on the advice of a physician. Do not use this product if you are nursing, pregnant, or intend to become pregnant within three months of use. For external use only. Apply only to small skin surface areas. Discontinue use and consult a physician in case of skin reaction or a blue-black darkening of the skin. In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. Do not use on children. Keep out of reach of children. Use only as directed. A mild transient stinging or minor redness may occur in people with sensitive skin. To test of sensitivity apply to an area of approximately 1 cm2 of unbroken skin on the inside of the arm. If no irritation occurs within 24 hours, begin treatment for up to 12 weeks. Discontinue use in case of irritation, rash, excessive inflammatory response of if a gradual blue-black darkening of the skin (exogenous ochronosis) occurs. Minor redness is acceptable, but where there is excessive irritation, a rash or other reaction, further treatment is not advised. Severe itching or reddening may occur, in which case the product should be discontinued and the physician notified immediately. Note slight darkening of the product is normal and does not affect its potency. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. Avoid contact with eyes. In case of accidental contact patient should rinse eyes thoroughly with water and contact a physician. A bitter taste and anesthetic effect may occur if applied to lips. Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication but when there is itching or vesicle formation or excessive inflammation response, further treatment is not advised. Close patient supervision is recommended. Treatment should be limited to small areas of the body. If no improvement is seen, discontinue use and consult a doctor/physician. Not for use longer than 3 months. Depigmentation (lightening) effect of this product may not be noticeable when used on very dark skin. Sun exposure should be avoided indefinitely by using a sunscreen agent, a sun block agent, or protective clothing to cover the bleached skin in order to prevent darkening from reoccurring. Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons.Fuente
Ficha oficial de Health Canada, licencia 80089256
Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias, consultado el 27 de octubre de 2026.
Contient des informations visées par la Licence du gouvernement ouvert – Canada (Santé Canada, BDPSNH)
Licence du gouvernement ouvert – Canada 2.0 (OGL-Canada 2.0)
La fórmula vendida en Europa con el mismo nombre puede ser diferente. Esta información no sustituye el consejo de un médico o farmacéutico.
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