MedPath

Dandruff

Equaline 311.007/311AK-AN Dandruff Shampoo, Everyday Clean 2 in 1

Approved
Approval ID

d7c4507e-7f74-4bcd-9b0e-0b097193a1a8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 28, 2025

Manufacturers
FDA

United Natural Foods, Inc. dba UNFI

DUNS: 943556183

Products 1

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

PYRITHIONE ZINC

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41163-024
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
PYRITHIONE ZINC
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2025
FDA Product Classification

INGREDIENTS (18)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT
GLYCOL DISTEARATEInactive
Code: 13W7MDN21W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ZINC CARBONATEInactive
Code: EQR32Y7H0M
Classification: IACT
SODIUM XYLENESULFONATEInactive
Code: G4LZF950UR
Classification: IACT
AMODIMETHICONE (800 CST)Inactive
Code: 363Z2T48P7
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)Inactive
Code: B16G315W7A
Classification: IACT
MAGNESIUM CARBONATE HYDROXIDEInactive
Code: YQO029V1L4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
PYRITHIONE ZINCActive
Quantity: 10 mg in 1 mL
Code: R953O2RHZ5
Classification: ACTIB

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Dandruff - FDA Drug Approval Details