111 Medco Benzoyl Peroxide Soap
FDA Label NDC 72811-137

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 111 Medco for the product 111 Medco Benzoyl Peroxide (NDC 72811-137). 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, otc - active ingredient, otc - purpose, indications & usage, 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.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient

Benzoyl peroxide 10%

Otc - Purpose

Purpose

Acne medication

Indications & Usage

Use for the treatment of acne; helps prevent new acne blemishes from forming

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • if you have very sensitive skin
  • if you 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 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 may be reduced by using the product less frequently or in a lower concentration.

Otc - Stop Use

Stop use and consult a doctor if

  • irritation becomes severe.

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.

Dosage & Administration

Directions

  • using warm water, wash the affected area for 1 to 2 minutes
  • rinse well and pat dry with a clean towel
  • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 the product
  • If irritation or sensitivity develops, stop use of both products and ask a doctor.

Storage And Handling

Other information Store at controlled room temperature 59° - 86°F (15° - 30°C)

Inactive Ingredient

Inactive ingredients

sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, ethylene/VA copolymer, zea mays (corn) starch, sodium tallowate, titanium dioxide, mineral oil, cocamidopropyl betaine, tetrasodium etidronate, sodium cocoate, glycerin, sodium chloride, tetrasodium EDTA

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