Benzoyl Peroxide Acne Wash 5% Suspension
FDA Label NDC 58980-332

15 label sections · Submitted to the FDA by Stratus Pharmaceuticals · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals for the product Benzoyl Peroxide Acne Wash 5% (NDC 58980-332). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Sensitive Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated above

Distributed by: Stratus Pharmaceuticals Inc.,
Miami, Florida 33186

Active Ingredients

Benzoyl peroxide 5%

Purpose

Acne medication

Uses

for the treatment of acne

Warnings

for external use only

Otc - Do Not Use

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Otc - When Using

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 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 may be reduced by using the product less frequently or in a lower concentration

Otc - Stop Use

Stop use and ask a doctor if

  • irritation becomes severe.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

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.

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 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 and ask a doctor.

Other Information

  • keep tightly closed
  • store at room temperature

Inactive Ingredients

Carbomer, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Glyceryl Stearate, Laureth-7, Magnesium Aluminum Silicate, Methyl Paraben, PEG-100 Stearate, Propylene Glycol, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Water, Xanthan Gum.

Questions Or Comments?

Call us at 1-800-442-7882

Principal Display Panel- 141.8 G Tube Box

NDC 58980-332-50

STRATUSCARE

BENZOYL
PEROXIDE

Acne Wash

5%

HELPS TO:

  • Keep skin clear
  • Dry oily skin
  • Clear acne pimples

    • STRATUS
    PHARMACEUTICALS INC

    Net Weight 5 oz. (141.8 g)

    Principal Display Panel (141.8 g Tube Box)

    Principal Display Panel (141.8 g Tube Box)

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