X OUT CLEANSING BODY- salicylic acid soap

X OUT CLEANSING BODY by

Drug Labeling and Warnings

X OUT CLEANSING BODY by is a Otc medication manufactured, distributed, or labeled by Bradford Soap Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient

Salicylic acid 1%

Purpose

Acne treatment

Keep out of reach of children.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation becomes severe.

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. 

Inactive ingredients

sodium cocoyl isethionate, stearic acid, water (aqua), sodium isethionate, fragrance (parfum), cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, polyethylene, disodium EDTA, pentasodium pentetate, titanium dioxide (Cl 77891)

Questions or comments?

Within the US 1-800-524-7952

X OUT CLEANSING BODY BAR product label

Drug Facts Active ingredient……………….….Purpose Salicylic acid 1%..................Acne Treatment Use for 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 contact with eyes. If contact occurs, rinse eyes thoroughly with water. 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. 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.	X OUT CLEANSING BODY BAR From the Makers of Proactiv® Salicylic acid acne treatment 5.0 OZ. 141 g	Drug Facts (continued) Inactive ingredients sodium cocoyl isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, disodium EDTA, pentasodium pentetrate, titanium dioxide Questions or comments: Within the US 1-800-524-7952 Distributed by The Proactiv Company LLC 100 N Seplveda Blvd. El Segundo, CA 90245 XOut.com Mae in the USA of Foreign and Domestic Components. XOut is a trademark of The Proactiv Company SanL       DT0063  DTBOXD19
	7   35786 02062   0

INGREDIENTS AND APPEARANCE

X OUT CLEANSING BODY 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11118-0119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.001 g  in 0.1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GALACTOARABINAN (UNII: SL4SX1O487)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11118-0119-1	141 g in 1 PACKAGE; Type 0: Not a Combination Product	06/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/01/2016

Labeler - Bradford Soap Works, Inc. (001201045)

Registrant - Bradford Soap Works, Inc. (001201045)

Establishment
Name	Address	ID/FEI	Business Operations
Bradford Soap Works, Inc.		001201045	manufacture(11118-0119) , label(11118-0119)