Benzoyl Peroxide Gel
FDA Label NDC 68071-2307

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Benzoyl Peroxide (NDC 68071-2307). 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, purpose, use, warnings, otc - do not use, when using this product, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

Active Ingredient

Benzoyl peroxide 5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Otc - Do Not Use

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

When Using This Product

n keep away from eyes, lips and mouth

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
  • using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

Directions

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

Other Information

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive Ingredients

carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water

Questions Or Comments?

1-800-645-2158

* Please review the disclaimer below.