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  5. Label Information: 111 Medco Benzoyl Peroxide

FDA Label for 111 Medco Benzoyl Peroxide

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

111 Medco Benzoyl Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product 111 Medco. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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