Proactiv Emergency Blemish Relief Cream
FDA Label NDC 11410-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alchemee, Llc for the product Proactiv Emergency Blemish Relief (NDC 11410-012). 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 ingredient, purpose, use, warnings, when using this product, otc - do not use, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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?

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Principal Display Panel - 9.45 G Tube Box

proactiv®

Emergency
Blemish
Relief

0.33 OZ. 9.45 g

benzoyl peroxide
acne medication

9.45g_carton_image (9.45g Carton Image)

9.45g_carton_image (9.45g Carton Image)

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