PROACTIV PLUS PORE TARGETING TREATMENT- benzoyl peroxide gel

Proactiv plus Pore Targeting Treatment by

Drug Labeling and Warnings

Proactiv plus Pore Targeting Treatment by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, VEE PAK, LLC, Apex International Mfg LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PROACTIV PLUS PORE TARGETING TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-046
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
Carboxypolymethylene (UNII: 0A5MM307FC)
Potassium Hydroxide (UNII: WZH3C48M4T)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-046-05	1 in 1 BOX	01/03/2013
1		89 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 11410-046-00	1 in 1 BOX	01/03/2013
2		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 11410-046-15	1 in 1 CARTON	08/01/2018
3		89 mL in 1 TUBE; 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	01/03/2013

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-046)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-046)