Acne Treatment Gel
FDA Label NDC 0363-0229

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Acne Treatment (NDC 0363-0229). 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 active ingredient, purpose, use, warnings, do not use if you, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When Using This Product

  • skin irritation and dryness is more likely to occur if you use aother 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 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, buring, itching, peeling or posible swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration

Stop Use And Ask A Doctor If

irritation becomes severe

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

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 daily 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

Inactive Ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Rear Label Text

This acne medication contains maximum strength benzoyl peroxide.  The micronized benzoyl peroxide formula goes to work immediately, releasing the medicine deep into the pore where pimples begin.

*Walgreens pharmacist survey

**This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Persa-Gel 10.

Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 600015

walgreens.com (c) 2017 Walgreen Co.

Principal Display Panel

*Walgreens pharmacist recommended

Maximum Strength Acne Treatment Gel

10% benzoyl peroxide/acne medication

NET WT 1 OZ (28 g)

Image Description (Mm02)

Image Description (Mm02)

229.001/229AC/AD

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