Obagi Tretinoin Cream, USP .05%
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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 treatment 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. 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 using tretinoin cream.
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 patients with this condition.
Drug Interactions. Concomitant topical medication, 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 dose should be adjusted to a level that you can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- 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
If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion
of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
DOSAGE AND ADMINISTRATION
Tretinoin gel or cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly.
Gel: Excessive application results in “pilling” of the gel, which minimizes the likelihood of over application by the patient. Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when those become able to tolerate the treatment. Alterations of vehicle, concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.
During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the cream on deep, previously
unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six
weeks of therapy may be required before definite beneficial effects are seen. Once the acne lesions have responded satisfactorily, it may be possible to maintain
the improvement with less frequent applications, or other dosage forms. Those treated with tretinoin preparations may use cosmetics, but the areas to
be treated should be cleansed thoroughly before the cream is applied (see Precautions).