TRETINOIN gel TRETINOIN cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Padagis US LLC

INN (שם בינלאומי):

TRETINOIN

הרכב:

TRETINOIN 0.25 mg in 1 g

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Tretinoin gel and cream are 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.

leaflet_short:

Tretinoin Gel, USP NDC CODE Strength Qty. 0574-2325-15 0.025% 15 g 0574-2325-45 0.025% 45 g 0574-2301-15 0.01% 15 g 0574-2301-45 0.01% 45 g Tretinoin Cream, USP NDC CODE Strength Qty. 0574-2201-20 0.1% 20 g 0574-2201-45 0.1% 45 g 0574-2205-20 0.05% 20 g 0574-2205-45 0.05% 45 g 0574-2225-20 0.025% 20 g 0574-2225-45 0.025% 45 g

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TRETINOIN- TRETINOIN GEL
TRETINOIN- TRETINOIN CREAM
PADAGIS US LLC
----------
TRETINOIN GEL, USP AND TRETINOIN CREAM, USP
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION:
Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical
treatment of acne
vulgaris. Each gram of tretinoin gel contains tretinoin in either of
two strengths, 0.025%
(0.25 mg) or 0.01% (0.1 mg) in a gel vehicle of hydroxypropyl
cellulose, butylated
hydroxytoluene, and alcohol 90% w/w. Each gram of tretinoin cream
contains tretinoin
in either of three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025%
(0.25 mg) 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. It has a molecular
weight of 300.44 and has
the following structural formula:
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 gel and cream are 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.
WARNINGS:
GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE. Keep
out of reach of children. Keep tube tightly closed. Do not expose to
heat or store at
temperatures above 120°F (49°C).
PRECAUTIONS:
_GENERAL:_
If a reaction suggesting sensitivity or chemical irritation occurs,
use of the medication
should be discontinued. Exposure to sunlight, including sunla