ACZONE Gel Precautions - MPI, US: SPL/PLR - RxReasoner

A total of 2161 subjects were treated with ACZONE Gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 to 63 years, was 56% female, and 58% …

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ACZONE Gel Precautions - MPI, US: SPL/PLR - RxReasoner

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A total of 2161 subjects were treated with ACZONE Gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 to 63 years, was 56% female, and 58% …

rxreasoner.com

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WARNINGS AND PRECAUTIONS ACZONE - Food And Drug …

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once daily. Rub in ACZONE Gel, 7.5%, gently and completely. If there is no improvement after 12 weeks, treatment with ACZONE Gel, 7.5% should be reassessed. 3 DOSAGE FORMS AND …

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ACZONE Gel Usage - MPI, US: SPL/PLR - RxReasoner

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After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE Gel, 7.5%, in a thin layer to the entire face once daily. In addition, a thin layer may …

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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ACZONE Gel, 5%, gently and completely. ACZONE Gel, 5%, is gritty with visible drug substance particles. Wash hands after application of ACZONE Gel, 5%. If there is no improvement after …

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HIGHLIGHTS OF PRESCRIBING INFORMATION WARNINGS …

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needed to use ACZONE® Gel, 7.5% safely and effectively. See full prescribing information for ACZONE ® Gel, 7.5%. ACZONE ® (dapsone) Gel, 7.5%, for topical use Initial U.S. Approval: …

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ACZONE Gel Pharmacology - MPI, US: SPL/PLR - RxReasoner

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The systemic exposure from ACZONE Gel, 7.5% is expected to be about 1% of that from a 100 mg oral dose. Long-term safety studies were not conducted with ACZONE Gel, 7.5%, …

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ACZONE NDA 207154 PAC REVIEW 2023 - FINAL

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Aczone (dapsone) gel, 7.5% is a sulfone that was initially approved in the United States on February 24, 2016. Aczone gel, 7.5% is currently indicated for the topical treatment of acne

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FDA Label For Aczone Gel Topical - Indications, Usage & Precautions

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Use ACZONE ® Gel, 5% exactly as your doctor tells you. Apply ACZONE ® Gel, 5% twice a day. Gently wash and pat dry the areas of your skin where you will apply ACZONE ® Gel, 5%. …

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Prescribing Information For ACZONE® Gel, 7.5

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A total of 2161 subjects were treated with ACZONE Gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 to 63 years, was 56% female, and 58% …

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FAQs about ACZONE Gel Precautions - MPI, US: SPL/PLR - RxReasoner Coupon?

How do I use Aczone gel?

Not for oral, ophthalmic, or intravaginal use. After the skin is gently washed and patted dry, apply approximately a pea-sized amount of ACZONE Gel, 7.5%, in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other affected areas once daily. Rub in ACZONE Gel, 7.5%, gently and completely. ...

How much Dapsone is in a gram of Aczone gel?

Each gram of ACZONE Gel, 7.5% contains 75 mg of dapsone in an off-white to yellow gel with suspended particles. None. Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with twice daily dapsone gel, 5%, treatment. ...

Does Aczone gel have a long-term safety study?

Long-term safety studies were not conducted with ACZONE Gel, 7.5%, however, in a long-term clinical study of dapsone gel, 5% treatment (twice daily), periodic blood samples were collected up to 12 months to determine systemic exposure of dapsone and its metabolites in approximately 500 subjects. ...

How long does Aczone gel last?

Wash your hands after applying ACZONE Gel, 7.5%. If your acne does not get better after using ACZONE Gel, 7.5% for 12 weeks, talk to your doctor about continuing treatment. What are the possible side effects of ACZONE Gel, 7.5%? ...

Can you use Aczone gel with benzoyl peroxide?

Especially, tell your doctor if you are using acne medicines that contain benzoyl peroxide. Use of benzoyl peroxide with ACZONE Gel, 7.5% at the same time may cause your skin or facial hair to temporarily turn yellow or orange at the site of application. How do I use ACZONE Gel, 7.5%? Use ACZONE Gel, 7.5% exactly as your doctor tells you to use it. ...

How do you store Aczone gel?

Store ACZONE Gel, 7.5%, at room temperature 68oF to 77oF (20oC to 25oC). Protect ACZONE Gel, 7.5% from freezing. Keep ACZONE Gel, 7.5% and all medicines out of the reach of children. General information about the safe and effective use of ACZONE Gel, 7.5%. ...