NDC 11410-037 X Out Shine Control
Salicylic Acid Gel Topical

Product Information

Product Code11410-037
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
X Out Shine Control
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Salicylic Acid
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
The Proactiv Company Llc
Labeler Code11410
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part333D
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-12-2017
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 11410-037-17

Package Description: 1 BOTTLE in 1 CARTON > 50 mL in 1 BOTTLE

Product Details

X Out Shine Control is a human over the counter drug product labeled by The Proactiv Company Llc. The generic name of X Out Shine Control is salicylic acid. The product's dosage form is gel and is administered via topical form.


What are X Out Shine Control Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)


* Please review the disclaimer below.

X Out Shine Control Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.

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.


* Please review the disclaimer below.