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  5. Label Information: Acne Spot Treatment

FDA Label for Acne Spot Treatment

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS

Acne Spot Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Cvs. 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.

Active Ingredient



Benzoyl Peroxide 10%


Purpose



Acne treatment


Uses



For the treatment of acne.


Warnings



For external use only.


Do Not Use



  • if you have very sensitive skin or are sensitive to Benzoyl Peroxide


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.
  • rinse right away with water if it gets in eyes.
  • 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, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop 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



  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer one to three times a day
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 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, use a sunscreen. Allow product to dry then follow directions in the sunscreen labeling. if sensitivity develops, discontinue use of both products and cpnsult a doctor.

Inactive Ingredients



Aluminum hydroxide, Bentonite, Carbomer, Glyceryl Stearate SE, Isopropyl myristate, Methylparaben, PEG-12, Potassium Hydroxide, Propylene Glycol, Propylparaben, Water


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