X Out Shine Control (Salicylic Acid) Gel [The Proactiv Company Llc] -

X OUT SHINE CONTROL (SALICYLIC ACID) GEL [THE PROACTIV COMPANY LLC]
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NDC	11410-037-17
Set ID	3cec7f65-6637-4ddc-9f2c-15a36fd7a159
Category	HUMAN OTC DRUG LABEL
Packager	THE PROACTIV COMPANY LLC
Generic Name
Product Class
Product Number
Application Number	PART333D

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient

Salicylic Acid 0.5%
Purpose

Acne Treatment
Use

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 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
- cleanse the skin thoroughly before applying this product.
- cover the entire affected area with a thin layer 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 once a day or every other day.
Inactive Ingredients

water, alcohol denat., butylene glycol, cyclopentasiloxane, glyceryl stearate, PEG-100 stearate, nylon-12, cyclohexasiloxane, PVM/MA decadiene crosspolymer, decylene glycol, sodium hydroxide, caprylyl glycol, hexylene glycol, aluminum starch octenylsuccinate, disodium EDTA, sarcosine, pentylene glycol, xanthan gum, 10-hydroxydecanoic acid,sebacic acid, 1,10-decanediol, phenoxyethanol, fragrance

Questions or comments?
Within US 1-800-524-7952
PRINCIPAL DISPLAY PANEL - 50 mL Carton

X OUT

SHINE CONTROL
OIL-FREE FORMULA
From the Makers of Proactiv®

1.7 FL. OZ. · 50 mL

salicylic acid acne treatment

Dist. by: The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
XOut.com ● Make in the USA of Foreign and Domestic Components
X Out is a trademark of The Proactiv Company Sàrl.

INGREDIENTS AND APPEARANCE

X OUT SHINE CONTROL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11410-037
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Butylene Glycol (UNII: 3XUS85K0RA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Nylon-12 (UNII: 446U8J075B)
Cyclomethicone 6 (UNII: XHK3U310BA)
Decylene Glycol (UNII: S57M60MI88)
Sodium Hydroxide (UNII: 55X04QC32I)
Caprylyl Glycol (UNII: 00YIU5438U)
Hexylene Glycol (UNII: KEH0A3F75J)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Sarcosine (UNII: Z711V88R5F)
Pentylene Glycol (UNII: 50C1307PZG)
Xanthan Gum (UNII: TTV12P4NEE)
10-hydroxydecanoic Acid (UNII: NP03XO416B)
Sebacic Acid (UNII: 97AN39ICTC)
1,10-decanediol (UNII: 5I577UDK52)
Phenoxyethanol (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11410-037-17	1 in 1 CARTON	10/12/2017
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	10/12/2017

Labeler - THE PROACTIV COMPANY LLC (080216357)

Name	Address	ID/FEI	Business Operations
Establishment
VEE PAK, LLC		874763303	manufacture(11410-037)

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Medic

X OUT SHINE CONTROL (SALICYLIC ACID) GEL [THE PROACTIV COMPANY LLC]

When using this product

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