X-OUT WASH-IN TREATMENT- benzoyl peroxide gel

X-Out Wash-In Treatment by

Drug Labeling and Warnings

X-Out Wash-In Treatment 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

Drug Facts

Active Ingredient

Benzoyl Peroxide 8.5%

Purpose

Acne treatment gel

Use

For the management of acne

Warnings

For external use only

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.
• 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

Water, Sodium Cocoyl Isethionate, Glycerin, Paraffin, Lauryl/Myristyl Benzoate, Coconut Acid, Linoleic Acid, Linolenic Acid, Menthol, Sodium Isethionate, Butylene Glycol, Dimethicone, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Phenoxyethanol, Fragrance.

Questions or comments?
Within US 1-800-524-7952

Distributed by The Proactiv Company, LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245
XOut.com ● Made in the USA of foreign and domestic components.
X Out is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 200 g Bottle Label

X
OUT

WASH-IN
TREATMENT

From the Makers of Proactiv®

benzoyl peroxide acne treatment
 7.0 OZ.  200 g

INGREDIENTS AND APPEARANCE

X-OUT WASH-IN TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-060
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 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-060-49	200 g in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2017	12/31/2019
2	NDC: 11410-060-10	1 in 1 CARTON	08/06/2019
2		10 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-060-15	200 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2019
4	NDC: 11410-060-00	75 g in 1 BOTTLE; Type 0: Not a Combination Product	08/08/2017	12/31/2019
5	NDC: 11410-060-05	1 in 1 CARTON	06/01/2019
5		75 g 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	08/08/2017

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-060)