REFISSA TRETINOIN (EMOLLIENT)- tretinoin cream

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Διαθέσιμο από:

ZO Skin Health, Inc.

INN (Διεθνής Όνομα):

Tretinoin

Σύνθεση:

Tretinoin 0.5 mg in 1 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs (see bullet 3 for populations in which effectiveness has not been established). REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing tretinoin.

Περίληψη προϊόντος:

Refissa is available in: 20 g tubes NDC 42851-012-20 40 g tubes NDC 42851-012-40 Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

REFISSA TRETINOIN (EMOLLIENT)- TRETINOIN CREAM
ZO SKIN HEALTH, INC.
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REFISSA
[TRETINOIN CREAM, USP (EMOLLIENT) 0.05%]
FOR TOPICAL USE ON THE FACE ONLY.
DESCRIPTION
Refissa [Tretinoin Cream, USP (Emollient) 0.05%], contains the active
ingredient tretinoin (a retinoid) in
an emollient cream base. Tretinoin is a yellow-to-orange crystalline
powder having a characteristic
floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly
soluble in polyethylene glycol 400,
octanol, and 100% ethanol. It is practically insoluble in water and
mineral oil, and it is insoluble in
glycerin. The chemical name for tretinoin is
(all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclonexen-1-
yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-
_trans_-retinoic acid and has a
molecular weight of 300.44. The structural formula is represented
below.
Refissa contains tretinoin at a concentration of 0.05% w/w in a
water-in-oil emulsion formulation
consisting of light mineral oil, sorbitol solution, hydroxyoctacosanyl
hydroxystearate; methoxy PEG-
22/dodecyl glycol copolymer, PEG-45/dodecyl glycol copolymer,
stearoxytrimethylsilane and stearyl
alcohol, dimethicone 50 cs, methylparaben, edetate disodium,
propylparaben, butylated hydroxytoluene,
citric acid monohydrate, and purified water.
CLINICAL PHARMACOLOGY
The exact mechanism of action of tretinoin is unknown although
retinoids are believed to exert an effect
on the growth and differentiation of various epithelial cells. When
applied topically, however, there
was no noted increase in desmosine, hydroxyproline, or elastin mRNA in
human skin. In addition, the
role of the irritative nature of this product in effecting the
positive effects attributed to this product for
its indication has not yet been fully determined.
The transdermal absorption of tretinoin from various topical
formulations ranged from 1% to 31% of
applied dose, depending on whether it was applied to healthy skin or
dermatitic skin. When percutaneous
absorption of Tretinoin Cream, USP (Emollient) 0