Obagi Tretinoin Cream .1%
Tretinoin Cream, USP
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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
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.
Use of the product should be discontinued if hypersensitivity to any of the
ingredients is noted.
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).
General. If a reaction suggesting sensitivity or chemical irritation occurs, use of the cream should be discontinued. Exposure to sunlight, including sunlamps,
should be minimized during the use of tretinoin, and those 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. Those 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 those under treatment with tretinoin.
Tretinoin preparations for acne treatment should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Topical use may induce severe local erythema and peeling at the site of application.
If the degree of local irritation warrants, you should be directed to use the cream less frequently, discontinue use temporarily, or discontinue use
altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in those with this condition.
Interactions: medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and
products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular
caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with tretinoin. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of tretinoin is begun.
The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the cream should either be
discontinued until the integrity of the skin is restored, or the cream should be adjusted to a level you can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of a tretinoin preparation. Some individuals
have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy (see Dosage and Administration Section).
If cream is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion
of the cream may lead to the same side effects as those associated with excessive oral intake of Vitamin A.