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Proactiv Emergency Blemish Relief

Medically reviewed on Apr 3, 2017

Dosage form: cream
Ingredients: Benzoyl Peroxide 5g in 100g
Labeler: The Proactiv Company, LLC
NDC Code: 11410-042

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Proactiv® Emergency Blemish Relief

Drug Facts

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.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop use 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
  • 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, cyclohexasiloxane, 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

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 9.45 g Tube Box

proactiv®

EMERGENCY
BLEMISH
RELIEF

0.33 OZ. 9.45 g

benzoyl peroxide
acne medication

PROACTIV EMERGENCY BLEMISH RELIEF 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-042
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
DIETHYLENE GLYCOL MONOETHYL ETHER 
CYCLOMETHICONE 5 
METHYLPROPANEDIOL 
STEARETH-2 
CYCLOMETHICONE 6 
STEARETH-21 
POLYQUATERNIUM-37 (3000 MPA.S) 
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE 
PROPYLENE GLYCOL 
PPG-1 TRIDECETH-6 
PANTHENOL 
ALLANTOIN 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:11410-042-091 TUBE in 1 BOX
19.45 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/09/2017
Labeler - The Proactiv Company, LLC (080216357)
Establishment
NameAddressID/FEIOperations
Vee Pak Inc.874763303MANUFACTURE(11410-042)
Establishment
NameAddressID/FEIOperations
KIK Custom Product - Rexdale Plant243547333MANUFACTURE(11410-042)

 
The Proactiv Company, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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