PROACTIV EXTRA STRENGTH FORMULA CLEANSER- benzoyl peroxide gel

Proactiv Extra Strength Formula Cleanser by

Drug Labeling and Warnings

Proactiv Extra Strength Formula Cleanser 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]

SPL UNCLASSIFIED SECTION

Active Ingredient

Benzoyl Peroxide 8.5%

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 on the right.
• apply a small amount to dampened skin.
• cover the entire affected area with a thin layer and rinse thoroughly 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

acrylates/C10-30 alkyl acrylate crosspolymer, butylene glycol, coconut acid, dimethicone, ethylhexylglycerin, fragrance, glycerin, lauryl/myristyl benzoate, linoleic acid, linolenic acid, menthol, paraffin, phenoxyethanol, sodium cocoyl isethionate, sodium hydroxide, sodium isethionate, water

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 - 120 mL Carton

proactiv®

EXTRA STRENGTH
FORMULA

cleanser

1                

benzoyl peroxide acne medication

4 FL. OZ. 120 mL

INGREDIENTS AND APPEARANCE

PROACTIV EXTRA STRENGTH FORMULA CLEANSER 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	8.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Butylene Glycol (UNII: 3XUS85K0RA)
Coconut Acid (UNII: 40U37V505D)
Dimethicone (UNII: 92RU3N3Y1O)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Lauryl/Myristyl Benzoate (UNII: N5RS934G6D)
Linoleic Acid (UNII: 9KJL21T0QJ)
Linolenic Acid (UNII: 0RBV727H71)
Menthol (UNII: L7T10EIP3A)
Paraffin (UNII: I9O0E3H2ZE)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Cocoyl Isethionate (UNII: 518XTE8493)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Isethionate (UNII: 3R36J71C17)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-066-00	1 in 1 CARTON	09/01/2018
1		120 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	09/01/2018

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-066)