PROACTIV EMERGENCY BLEMISH RELIEF - benzoyl peroxide cream 
Alchemee, 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 

Use

for the management of acne                 

Warnings

For external use only

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.
  • 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.
  • clean 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, cyclopentasiloxane, ethoxydiglycol, steareth-2, methylpropanediol, steareth-21, polyquaternium-37, propylene glycol dicaprylate/dicaprate, phenoxyethanol, caprylyl glycol, fragrance, panthenol, allantoin, ethylhexylglycerin, PPG-1 trideceth-6

Questions or comments?

1-800-950-4695

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign and
Domestic Components Questions
1-800-950-4695 proactiv.com

Proactiv is a trademark of
Taro Pharmaceutical U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 9.45 g Tube Box

proactiv®

EMERGENCY
BLEMISH
RELIEF

0.33 OZ. (9.45 g)

benzoyl peroxide
acne medication

unit carton image
PROACTIV EMERGENCY BLEMISH RELIEF  
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-012
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)  
STEARETH-21 (UNII: 53J3F32P58)  
POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-012-091 in 1 BOX02/15/2013
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 FINALpart333D02/15/2013
Labeler - Alchemee, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
Vee Pak Inc.874763303manufacture(11410-012)
Establishment
NameAddressID/FEIBusiness Operations
Apex International Mfg LLC079110793manufacture(11410-012)

Revised: 10/2022
Document Id: 78ead50f-1d63-40d8-8944-5460285e0f0e
Set id: 72bb45ca-3f68-47be-928e-755cc66419d9
Version: 6
Effective Time: 20221013
 
Alchemee, LLC