TRETINOIN CREAM- tretinoin cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Obagi Cosmeceuticals LLC

INN (International ime):

TRETINOIN

Sastav:

TRETINOIN 1 mg in 1 g

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

Proizvod sažetak:

Tretinoin is supplied as: Tretinoin Cream NDC Code Strength Quantity 62032-414-20 0.025% Cream 20 g 62032-412-20 0.05% Cream 20 g 62032-417-20 0.1% Cream 20 g

Status autorizacije:

New Drug Application

Svojstava lijeka

TRETINOIN CREAM- TRETINOIN CREAM
OBAGI COSMECEUTICALS LLC
----------
TRETINOIN CREAM
FOR TOPICAL USE ONLY
DESCRIPTION
Tretinoin Cream is used for the topical treatment of acne vulgaris.
Tretinoin Cream
contains tretinoin in one of three strengths, 0.1%, 0.05%, or 0.025%
by weight, in a
hydrophilic cream vehicle of stearic acid, isopropyl myristate,
polyoxyl 40 stearate,
stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene,
and purified water.
Chemically, tretinoin is _all_-_trans_-retinoic acid and has the
following structure:
CLINICAL PHARMACOLOGY
Although the exact mode of action of tretinoin is unknown, current
evidence suggests
that topical tretinoin decreases cohesiveness of follicular epithelial
cells with decreased
microcomedo formation. Additionally, tretinoin stimulates mitotic
activity and increased
turnover of follicular epithelial cells causing extrusion of the
comedones.
INDICATIONS AND USAGE
Tretinoin is indicated for topical application in the treatment of
acne vulgaris. The safety
and efficacy of the long-term use of this product in the treatment of
other disorders
have not been established.
CONTRAINDICATIONS
Use of the product should be discontinued if hypersensitivity to any
of the ingredients is
noted.
PRECAUTIONS
GENERAL
If a reaction suggesting sensitivity or chemical irritation occurs,
use of the medication
should be discontinued. Exposure to sunlight, including sunlamps,
should be minimized
during the use of tretinoin, and patients with sunburn should be
advised not to use the
product until fully recovered because of heightened susceptibility to
sunlight as a result
of the use of tretinoin. Patients who may be required to have
considerable sun exposure
due to occupation and those with inherent sensitivity to the sun
should exercise
particular caution. Use of sunscreen products and protective clothing
over treated areas
is recommended when exposure cannot be avoided. Weather extremes, such
as wind
or cold, also may be irritating to patients under treatment with
tretinoin.
Tret