PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR- benzoyl peroxide lotion

Proactivplus Skin Smoothing Exfoliator by

Drug Labeling and Warnings

Proactivplus Skin Smoothing Exfoliator by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, KIK Holdco Company Inc. 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 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 above.
• apply a small amount to dampened skin and gently massage for 1 to 2 minutes.
• 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

water, sodium cocoyl isethionate, glycerin, paraffin, lauryl/myristyl benzoate, coconut acid, tocopherol, linoleic acid, linolenic acid, butylene glycol, dimethicone, ethylhexylglycerin, acrylates/c10-30 alkyl acrylate crosspolymer, glycolic acid, sodium isethionate, sodium hydroxide, phenoxyethanol , fragrance.

Questions or comments?

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by: The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245 ● proactive.com
Manufactured in Canada.
Proactiv+ is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 60 mL Carton

proactiv+

Skin
Smoothing
Exfoliator

2 FL. OZ. 60 mL

benzoyl peroxide
acne treatment

PRINCIPAL DISPLAY PANEL - 177.4 mL Carton

proactive+

Skin
Smoothing
Exfoliator

 6 FL. OZ. 177.4 mL

benzoyl peroxide
acne treatment

INGREDIENTS AND APPEARANCE

PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-011
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL/MYRISTYL BENZOATE (UNII: N5RS934G6D)
Coconut Acid (UNII: 40U37V505D)
Tocopherol (UNII: R0ZB2556P8)
Linoleic Acid (UNII: 9KJL21T0QJ)
Linolenic Acid (UNII: 0RBV727H71)
Butylene Glycol (UNII: 3XUS85K0RA)
Dimethicone (UNII: 92RU3N3Y1O)
Ethylhexylglycerin (UNII: 147D247K3P)
Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)
Glycolic Acid (UNII: 0WT12SX38S)
Sodium Isethionate (UNII: 3R36J71C17)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)
Paraffin (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-011-68	1 in 1 BOX	01/25/2013
1		177.4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-011-82	1 in 1 BOX	01/25/2013
2		60 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	01/25/2013

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-011)