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Selenium Sulfide

Selenium Sulfide 2.25% Shampoo

Approved
Approval ID

dacbcc5a-d37c-4ea3-8f47-35abb64c7519

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2022

Manufacturers
FDA

Bi-Coastal Pharma International LLC

DUNS: 078397428

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 Code42582-900
Product Classification
G
Generic Name
Selenium Sulfide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 2, 2020
FDA Product Classification

INGREDIENTS (23)

ammonium lauryl sulfateInactive
Code: Q7AO2R1M0B
Classification: IACT
diazolidinyl ureaInactive
Code: H5RIZ3MPW4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
ureaInactive
Code: 8W8T17847W
Classification: IACT
Selenium SulfideActive
Quantity: 22.5 mg in 1 mL
Code: Z69D9E381Q
Classification: ACTIB
panthenolInactive
Code: WV9CM0O67Z
Classification: IACT
PPG-2 hydroxyethyl coco/isostearamideInactive
Code: EK4J71ZKEQ
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
.alpha.-tocopherol acetateInactive
Code: 9E8X80D2L0
Classification: IACT
pyrithione zincInactive
Code: R953O2RHZ5
Classification: IACT
cocamidopropyl betaineInactive
Code: 5OCF3O11KX
Classification: IACT
fluorescein sodiumInactive
Code: 93X55PE38X
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
magnesium aluminum silicateInactive
Code: 6M3P64V0NC
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
medium-chain triglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
chromic oxideInactive
Code: X5Z09SU859
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT

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Selenium Sulfide - FDA Drug Approval Details