Usual Adult Dose for Acne

Topical gel 5%: Apply approximately a pea-sized amount in a thin layer to the acne affected areas twice a day.
Topical gel 7.5%: Apply approximately a pea-sized amount in a thin layer to the entire face (and other affected areas) once a day.

Use: For the topical treatment of acne vulgaris

Usual Pediatric Dose for Acne

12 years or older:

• Topical gel 5%: Apply approximately a pea-sized amount in a thin layer to the acne affected areas twice a day.
• Topical gel 7.5%: Apply approximately a pea-sized amount in a thin layer to the entire face (and other affected areas) once a day.

Renal Dose Adjustments

No data available

Liver Dose Adjustments

No data available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 12 years; the topical gel 5% is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

No data available

Other Comments

Administration advice:

• For topical use only; not for oral, ophthalmic, or intravaginal use
• Gently wash and pat dry the skin before using this drug.
• Rub in gently and completely.
• Wash hands after using this drug.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Protect from freezing.

• The topical gel 5% is gritty; drug substance particles may be seen in the gel.
• Therapy should be reassessed if there is no improvement after 12 weeks.
• Coadministration with benzoyl peroxide may cause temporary localized yellow or orange discoloration of the skin and facial hair.

• Read the US FDA-approved patient labeling (Patient Information).
• Stop this drug and seek immediate medical attention if cyanosis develops.
• Seek medical attention if signs/symptoms suggesting hemolytic anemia develop.
• Do not apply to eyes, mouth, or mucous membranes.