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X Out Shine Control by THE PROACTIV COMPANY LLC

Medically reviewed on January 31, 2018

Dosage form: gel
Ingredients: Salicylic Acid 0.5g in 100mL
Labeler: THE PROACTIV COMPANY LLC
NDC Code: 11410-037

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.

X Out Shine Control

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 ‚óŹ Make in the USA of Foreign and Domestic Components
X Out is a trademark of The Proactiv Company Sàrl.

X OUT SHINE CONTROL 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-037
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Alcohol 
Butylene Glycol 
Cyclomethicone 5 
Glyceryl Monostearate 
Peg-100 Stearate 
Nylon-12 
Cyclomethicone 6 
Decylene Glycol 
Sodium Hydroxide 
Caprylyl Glycol 
Hexylene Glycol 
Aluminum Starch Octenylsuccinate 
Edetate Disodium Anhydrous 
Sarcosine 
Pentylene Glycol 
Xanthan Gum 
10-hydroxydecanoic Acid 
Sebacic Acid 
1,10-decanediol 
Phenoxyethanol 
Packaging
#Item CodePackage Description
1NDC:11410-037-171 BOTTLE in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/12/2017
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIOperations
VEE PAK, LLC874763303manufacture(11410-037)

 
THE PROACTIV COMPANY LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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