PROACTIV PLUS PORE TARGETING TREATMENT- benzoyl peroxide gel
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+ Pore Targeting Treatment

Drug Facts

Active ingredient

Benzoyl peroxide 2.5%

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, glycerin, prunus amygdalus dulcis (sweet almond) oil, polysorbate 80, polysorbate 60, sorbitan stearate, carbomer, potassium hydroxide, disodium EDTA, 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

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
Manufactured in Canada ● proactiv.com

Proactiv+ is a trademark of the Proactiv Company Sàrl

PRINCIPAL DISPLAY PANEL - 30 mL

proactiv+
Pore Targeting Treatment
1 FL OZ 30 mL
benzoyl peroxide acne treatment

PRINCIPAL DISPLAY PANEL - 89 mL

proactiv+
Pore Targeting Treatment
3 FL OZ 89 mL
benzoyl peroxide acne treatment

PROACTIV PLUS PORE TARGETING TREATMENT
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Glycerin (UNII: PDC6A3C0OX)
Almond Oil (UNII: 66YXD4DKO9)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Polysorbate 60 (UNII: CAL22UVI4M)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Potassium Hydroxide (UNII: WZH3C48M4T)
Edetate Disodium (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-009-89	1 in 1 BOX	01/03/2013	06/30/2019
1		89 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC:11410-009-12	1 in 1 BOX	01/03/2013	06/30/2019
2		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC:11410-009-23	1 in 1 BOX	01/03/2013	06/30/2019
3		60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	01/03/2013	06/30/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Name	Address	ID/FEI	Business Operations
Establishment
VEE PAK, LLC		874763303	manufacture(11410-009)

Name	Address	ID/FEI	Business Operations
Establishment
KIK Holdco Company Inc		243547333	manufacture(11410-009)

Revised: 11/2017

Document Id: fffddc14-e32c-4ecf-a2cc-b02fc147ecca

Set id: bcd4fa2d-7acc-4678-9c19-22b4115880d1

Version: 5

Effective Time: 20171121

THE PROACTIV COMPANY LLC