Everyday Clean Dandruff
TopCare 153.008/153AZ rev1 - BD Everyday Clean Dandruff Shampoo
Approved
Approval ID
fc568c8f-0d59-4b26-8f72-ea70e4316687
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Topco Associates LLC
DUNS: 006935977
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 Code36800-153
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pyrithione Zinc
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 7, 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 (1300 CST)Inactive
Code: 3V7U636DWN
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