Furthermore, such studies are not always predictive of human response; therefore, adapalene and benzoyl peroxide gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus.No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5 mg adapalene/kg/day, up to 25 times (mg/mDermal teratology studies conducted in rats and rabbits at doses of 0.6 to 6 mg adapalene/kg/day [25 to 59 times (mg/mIt is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of adapalene and benzoyl peroxide gel. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Nonprescription (over the counter) adapalene comes as a gel to apply to the skin. To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or Table 1: Drug Related Adverse Events Reported in Clinical Trials by At Least 1% of Patients Treated For 12 WeeksTable 2: Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N = 553) Treatment Emergent Signs and SymptomsTable 3: Clinical Efficacy of Adapalene and Benzoyl Peroxide Gel at Week 12What should I tell my doctor before using adapalene and benzoyl peroxide gel?How should I use adapalene and benzoyl peroxide gel?What should I avoid while using adapalene and benzoyl peroxide gel?What are the possible side effects of adapalene and benzoyl peroxide gel?How should I store adapalene and benzoyl peroxide gel?Keep adapalene and benzoyl peroxide gel and all medicines out of the reach of children.General information about adapalene and benzoyl peroxide gelWhat are the ingredients in adapalene and benzoyl peroxide gel?Keep this and all medications out of the reach of children. Make Differin Gel a part of your daily skincare routine. 51672-1364-6

If you are using a bottle of adapalene solution, be sure to store it upright.Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.

Do not use adapalene and benzoyl peroxide gel in or on your mouth, eyes, or vagina. (See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Adapalene and benzoyl peroxide gel 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.For topical use only; adapalene and benzoyl peroxide gel 0.1%/2.5% is not for oral, ophthalmic, or intravaginal use.Apply a thin film of adapalene and benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide.

August 18, 2020 Treatment response was defined as the percent of subjects who had a two grade improvement and rated 'Clear' and 'Almost Clear' at Week 12 based on the Investigator's Global Assessment (IGA) and mean absolute change from baseline at Week 12 in both inflammatory and non-inflammatory lesion counts. Every Day. ( 1 ) A retinoid is simply a derivative of vitamin A.

You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources.Adapalene did not exhibit mutagenic or genotoxic effects Bacterial mutagenicity assays (Ames test) with benzoyl peroxide has provided mixed results, mutagenic potential was observed in a few but not in a majority of investigations. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. It works by affecting the growth of cells and decreasing swelling and inflammation.. Adapalene is available under the following different brand names: Differin.

If you have any questions about adapalene and benzoyl peroxide gel, talk with your doctor or pharmacist.Adapalene and benzoyl peroxide gel is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 9 years of age and older.Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.It is not known if adapalene and benzoyl peroxide gel is safe and effective in children younger than 9 years old.Before you use adapalene and benzoyl peroxide gel, tell your doctor if you:Especially tell your doctor if you use any other medicine for acne. Adapalene and benzoyl peroxide gel is for skin use only.

Adapalene is in a class of medications called retinoid-like compounds.

Acne might appear worse during the first few weeks of using adapalene gel because this medicine works on pimples from inside the skin. The median age of subjects was 11 years and 24% were males.