OTC Medication Information: X OUT CLEANSING BODY

X OUT CLEANSING BODY- salicylic acid soap
Bradford Soap Works, Inc.

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.

Drug Facts Active 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

Bradford XOut
(click image for full-size original)

X OUT CLEANSING BODY
salicylic acid soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11118-0119
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.001 g in 0.1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM COCOYL ISETHIONATE
STEARIC ACID
WATER
SODIUM ISETHIONATE
COCAMIDOPROPYL HYDROXYSULTAINE
SODIUM CHLORIDE
GALACTOARABINAN
HIGH DENSITY POLYETHYLENE
EDETATE DISODIUM ANHYDROUS
PENTASODIUM PENTETATE
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11118-0119-1 141 g in 1 PACKAGE None
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 Operations
Bradford Soap Works, Inc. 001201045 manufacture (11118-0119)

Revised: 11/2022 Bradford Soap Works, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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