X OUT CLEANSING BODY

Main information

  • Trade name:
  • X OUT CLEANSING BODY- salicylic acid soap
  • Composition:
  • SALICYLIC ACID 0.001 g in 0.1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • X OUT CLEANSING BODY- salicylic acid soap
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Acne treatment for the management of acne - irritation becomes severe.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 11118-0119-1
  • Last update:
  • 02-06-2019

Summary of Product characteristics: dosage, interactions, side effects

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.

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X-Out Cleansing - 0119

Drug Facts

Active ingredient

Salicylic acid 1%

Purpos e

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.

Us e

for the management of acne

Warnings

For external use only

When using this product

skin irritation and dryness are more likely to occur if you use another topical acne medicine 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

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

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 ststed above.

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

X OUT

CLEANSING BODY BAR

From the Makers of PROACTIVE®

salicylic acid acne treatment

5.0 OZ. 141 g

Dist by: Guthy-Renker® LLC PO Box 14383 Palm Desert, CA 92255-4383

XOut.com/reorder Made in the USA of Foreign and Domestic Components

XOut is a trademark in the United States and may be a trademark in other countries.

X OUT CLEANSING BODY

salicylic acid soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11118 -0 119

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

0 .0 0 1 g in 0 .1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM CO CO YL ISETHIO NATE (UNII: 518 XTE8 49 3)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM ISETHIO NATE (UNII: 3R36 J71C17)

CO CAMIDO PRO PYL HYDRO XYSULTAINE (UNII: 6 2V75NI9 3W)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

GALACTO ARABINAN (UNII: SL4SX1O48 7)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

Bradford Soap Works, Inc.

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

PENTASO DIUM PENTETATE (UNII: 9 6 1TOZ5L7T)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:11118 -0 119 -1

141 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /0 1/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 6 /0 1/20 16

Labeler -

Bradford Soap Works, Inc. (001201045)

Registrant -

Bradford Soap Works, Inc. (001201045)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bradfo rd So ap Wo rks, Inc.

0 0 120 10 45

ma nufa c ture (11118 -0 119 )

Revised: 11/2018