Proactiv Extra Strength Formula Treatmentbenzoyl peroxide acne medication

Proactiv by

Drug Labeling and Warnings

Proactiv by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV  EXTRA STRENGTH FORMULA TREATMENT- 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.

----------

Proactiv Extra Strength Formula Treatment
benzoyl peroxide acne medication

Active Ingredient

Benzoyl Peroxide 7%

Purpose

Acne Treatment gel

Use

For the management of acne

Warnings

For external use only

When using this product

• 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 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 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, cyclotetrasiloxane, cyclopentasiloxane, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ceteareth-20, carbomer, panthenol, allantoin, xanthan gum, sodium hydroxide, 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
proactiv.com
Made in the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 60 mL Carton

proactiv®

EXTRA STRENGTH
FORMULA

treatment

3                

benzoyl peroxide acne medication

2 FL. OZ. 60 mL

PROACTIV   EXTRA STRENGTH FORMULA TREATMENT
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	7 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexylglycerin (UNII: 147D247K3P)
Cyclomethicone 4 (UNII: CZ227117JE)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Dimethicone (UNII: 92RU3N3Y1O)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Carboxypolymethylene (UNII: 0A5MM307FC)
Panthenol (UNII: WV9CM0O67Z)
Allantoin (UNII: 344S277G0Z)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Hydroxide (UNII: 55X04QC32I)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-065-00	1 in 1 CARTON	05/01/2017	06/30/2019
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/01/2017	06/30/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-065)

Revised: 9/2018

Document Id: 90294107-0580-4c6f-96d2-d35fdfd578d7

34390-5

Set id: 5f02e65d-a0a9-434b-aafa-873018a58c16

Version: 2

Effective Time: 20180901