TRETINOIN (EMOLLIENT)- tretinoin cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tretinoin (UNII: 5688UTC01R) (Tretinoin - UNII:5688UTC01R)

Available from:

ZO Skin Health, Inc.

INN (International Name):

Tretinoin

Composition:

Tretinoin 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) 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). TRETINOIN CREAM, USP (EMOLLIENT) 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. - Tretinoin Cream, USP

Product summary:

Tretinoin Cream, USP (Emollient) 0.05% is available in this size: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRETINOIN (EMOLLIENT)- TRETINOIN CREAM
ZO SKIN HEALTH, INC.
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TRETINOIN CREAM, USP (EMOLLIENT) 0.05%
FOR TOPICAL USE ON THE FACE ONLY.
DESCRIPTION
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.
Tretinoin is available as Tretinoin Cream, USP (Emollient) 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