Dermapak Plus Recall
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Questions & Answers
Side Effects & Adverse Reactions
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).
For external use only. Not for deep or puncture wounds. Avoid contact with eyes.
In case of accidental ingestion contact a physician or poison control center immediately. If condition worsens or does not improve within 7 days, consult a doctor.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
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.
A moisture barrier that prevents and helps heal skin irritation from: urine, diarrhea, perspiration, fistula damage, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching
There is currently no drug history available for this drug.
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 (denatured with tert-butyl alcohol and brucine sulfate) 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: