Onexton

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with benzoyl peroxide and clindamycin topical unless your doctor tells you to.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using benzoyl peroxide and clindamycin topical and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. This medication can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide and clindamycin topical, or skin discoloration may occur.

Benzoyl peroxide can bleach hair or fabrics. Do not let this medicine come into contact with clothing, hair, or colored towels or bed linens.

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide and clindamycin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

The following adverse reaction is described in more detail in the WARNINGS AND PRECAUTIONS section of the label:

• Colitis [See WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates observed in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).

During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around week 4 and were near or improved from baseline levels by week 12. The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at week 12 are shown in Table 1.

Table 1: Local Skin Reactions -Percent of Subjects with Symptoms Present. Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243)

Postmarketing Experience

Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.

Read the entire FDA prescribing information for Onexton (Cindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75)

Onexton is a prescription medication used to treat acne in patients 12 and older.

Onexton comes as a gel to be applied to the affected skin once-daily.

Common side effects of Onexton include skin irritation, burning sensation, itching, and rash. 

This medicine can cause a rare but serious allergic reaction or severe skin irritation. Stop using this medicine and get emergency medical help if you have: hives, itching; difficult breathing, feeling light-headed; or swelling of your face, lips, tongue, or throat.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Benzoyl peroxide can cause a rare but serious allergic reaction or severe skin irritation. Before you start using this medicine, you may choose to apply a "test dose" to see if you have a reaction. Apply a very small amount of the medicine to 1 or 2 small acne areas every day for 3 days in a row. If there is no reaction, begin using the full prescribed amount on the 4th day.

Wash your hands before and after applying this medicine.

Wash your face with a mild cleanser (not soap) and pat the skin dry with a clean towel.

Benzoyl peroxide and clindamycin topical is usually applied twice daily, in the morning and evening.

Avoid getting this medicine in your eyes, mouth, or nose (or in the creases of your nose), or on your lips. If it does get into any of these areas, wash with water. Do not apply this medicine to sunburned, windburned, dry, chapped, irritated, or broken skin.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

If you receive more than one supply of Acanya or Duac gel, store the unopened container in a refrigerator until you are ready to start using it. Do not freeze.

Once in use, store the gel at room temperature away from moisture and heat. Do not freeze. Throw away any unused medicine after the expiration date on the label has passed. Duac has an expiration date of 60 days. Acanya has an expiration date of 10 weeks. BenzaClin has an expiration date of 3 months.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms include bloody or watery diarrhea, which may result if you absorb this medicine through your skin by applying too much.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with benzoyl peroxide and clindamycin topical unless your doctor tells you to.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using benzoyl peroxide and clindamycin topical and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. This medication can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide and clindamycin topical, or skin discoloration may occur.

Benzoyl peroxide can bleach hair or fabrics. Do not let this medicine come into contact with clothing, hair, or colored towels or bed linens.

Use Onexton as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• If you get Onexton in any of these areas, rinse well with water.
• Wash your hands before and after use.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on cuts, scrapes, or damaged skin.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where Onexton is used.
• Dry skin.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Store upright with the cap on.
• Throw away any part not used after 10 weeks.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.