OTC Medication Information: X Out Cleansing Body Bar

X OUT CLEANSING BODY BAR- salicylic acid soap
THE PROACTIV COMPANY LLC

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.

Proactiv XOut Cleansing Body Bar Carton

Drug Facts

Active ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

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.

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.
  • 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, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, disodium EDTA, pentasodium pentetate, titanium dioxide

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. XOut is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL — 141 g Applicator Carton

X®
OUT

CLEANSING BODY BAR

From the Makers of Proactiv®

salicylic acid acne treatment
5.0 OZ. • 141 g

Proactiv XOut Cleansing Body Bar Carton
(click image for full-size original)
X OUT CLEANSING BODY BAR
salicylic acid soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 mg in 100 g
Inactive Ingredients
Ingredient Name Strength
SODIUM COCOYL ISETHIONATE
STEARIC ACID
WATER
SODIUM ISETHIONATE
COCAMIDOPROPYL HYDROXYSULTAINE
SODIUM CHLORIDE
EDETATE DISODIUM
PENTASODIUM PENTETATE
TITANIUM DIOXIDE
Galactoarabinan
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11410-007-37 1 APPLICATOR in 1 CARTON contains a APPLICATOR
1 141 g in 1 APPLICATOR This package is contained within the CARTON (11410-007-37)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 12/31/2012
Labeler — THE PROACTIV COMPANY LLC (080216357)
Establishment
Name Address ID/FEI Operations
Bradford Soap Works 001201045 manufacture (11410-007)

Revised: 12/2017 THE PROACTIV COMPANY LLC

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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