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SELENIUM SULFIDE

SELENIUM SULFIDE LOTION, USP 2.5%

Approved
Approval ID

92bd55e7-0a24-4551-975f-a059a8b7d633

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 26, 2021

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

selenium sulfide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-2166
Application NumberANDA088228
Product Classification
M
Marketing Category
C73584
G
Generic Name
selenium sulfide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 16, 2019
FDA Product Classification

INGREDIENTS (13)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BENTONITEInactive
Code: A3N5ZCN45C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
LAURIC DIETHANOLAMIDEInactive
Code: I29I2VHG38
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
DISODIUM COCOAMPHODIACETATEInactive
Code: 18L9G3U51M
Classification: IACT
GLYCOL STEARATEInactive
Code: 0324G66D0E
Classification: IACT
GLYCERYL RICINOLEATEInactive
Code: ZUE0CEL42O
Classification: IACT
CAPTANInactive
Code: EOL5G26Q9F
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SELENIUM SULFIDEActive
Quantity: 25 mg in 1 mL
Code: Z69D9E381Q
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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SELENIUM SULFIDE - FDA Drug Approval Details