Reform
FDA Label NDC 70911-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schweiger Dermatology Group for the product Reform (NDC 70911-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient(s), purpose, use, warnings, when using this product, do not use if you, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient(s)

→ Purpose

→ Use

→ Warnings

→ When Using This Product

→ Do Not Use If You

→ Stop Use And Ask A Doctor If

→ Directions

→ Inactive Ingredients

→ Questions

→ Otc - Keep Out Of Reach Of Children

→ Principal Display Panel - 30 Ml Bottle Label

Other

Drug Facts

Distributed by: Schweiger Dermatology Group
New York, New York 10019

Active Ingredient(S)

Benzoyl Peroxide 5.25%

Purpose

Acne Treatment

Use

For the treatment of Acne.

Warnings

For external use only.

When Using This Product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

avoid unnecessary sun exposure and use a sunscreen
avoid contact with the eyes, lips, and mouth
avoid contact with hair and dyed fabrics, which may be bleached by this product
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation maybe reduced by using the product less frequently or in a lower concentration

Do Not Use If You

have very sensitive skin
are sensitive to benzoyl peroxide

Stop Use And Ask A Doctor If

irritation becomes severe

Directions

Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer one to three times daily.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If bothersome dryness or peeling occurs, reduce the application to once a day or every other day.
If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.