Proactiv® Emergency Blemish Relief

Proactiv Emergency Blemish Relief by

Drug Labeling and Warnings

Proactiv Emergency Blemish Relief by is a Otc medication manufactured, distributed, or labeled by The Proactiv Company, LLC, Vee Pak Inc., KIK Custom Product - Rexdale Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV EMERGENCY BLEMISH RELIEF- benzoyl peroxide cream 
The Proactiv Company, LLC

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.

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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

PRINCIPAL DISPLAY PANEL - 9.45 g Tube Box
PROACTIV EMERGENCY BLEMISH RELIEF 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
STEARETH-2 (UNII: V56DFE46J5)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
STEARETH-21 (UNII: 53J3F32P58)  
POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-042-091 in 1 BOX03/09/201706/30/2019
19.45 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/09/201706/30/2019
Labeler - The Proactiv Company, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
Vee Pak Inc.874763303MANUFACTURE(11410-042)
Establishment
NameAddressID/FEIBusiness Operations
KIK Custom Product - Rexdale Plant243547333MANUFACTURE(11410-042)

Revised: 4/2017
 
The Proactiv Company, LLC