FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Keep out of reach of children.Keep tube tightly closed.Do not expose to heat or store at temperatures above 120°F (49°C).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TRETIN•X cream 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.
History
There is currently no drug history available for this drug.
Other Information
TRETIN•X Cream,USP is used for the topical treatment of acne vulgaris.Each gram of TRETIN•X cream contains tretinoin in either of five strengths,0.1% (1 mg), 0.075% (0.75 mg) 0.05% (0.5 mg), 0.0375% (0.375 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:
C20H28O2
Sources
Tretin.x Manufacturers
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Onset Dermatologics Llc
Tretin.x | Onset Dermatologics Llc
TRETIN•X 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.
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 the patients become able to tolerate the treatment.
Alterations of vehicle, drug 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 medication 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.
Patients treated with TRETIN•X preparations may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see Precautions).
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