FDA Label for Proactiv Emergency Blemish Relief

View Indications, Usage & Precautions

Proactiv Emergency Blemish Relief Product Label

The following document was submitted to the FDA by the labeler of this product Alchemee, Llc. 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.

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Drug Facts

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactive.com ● Made in the USA of Foreign and Domestic Components

Proactiv is a trademark of The Proactiv Company Sàrl.


Active Ingredient



Benzoyl peroxide 5%


Purpose



Acne treatment gel


Use



for the management of acne                 


Warnings



For external use only


When Using This Product



  • do not use this product more than three times per day.
  • skin irritation and dryness are 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 - Do Not Use



Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop Use And Ask 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.


Directions



  • Sensitivity 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 the directions stated below.
  • cleanse 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 of both products and ask a doctor.

Inactive Ingredients



water, ethoxydiglycol, cyclopentasiloxane, methylpropanediol, steareth-2, cyclopentasiloxane, steareth-21, polyquaternium-37, propylene glycol dicaprylate/dicaprate, propylene glycol, PPG-1 trideceth-6, panthenol, allantoin, diazolidinyl urea, methylparaben, propylparaben, fragrance.


Questions Or Comments?



Within US 1-800-950-4695


Principal Display Panel - 9.45 G Tube Box



proactiv®

Emergency
Blemish
Relief

0.33 OZ. 9.45 g

benzoyl peroxide
acne medication


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