MedPath
FDA Approval

Dandruff

April 28, 2025

HUMAN OTC DRUG LABEL

Pyrithione Zinc(10 mg in 1 mL)

Registrants (1)

Consumer Product Partners, LLC

119091520

Manufacturing Establishments (1)

Consumer Product Partners, LLC

Retail Business Services, LLC

Consumer Product Partners, LLC

119091520

Products (1)

Dandruff

72476-311

M032

OTC Monograph Drug (C200263)

TOPICAL

April 28, 2025

WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0Class: IACT
GLYCOL DISTEARATEInactive
Code: 13W7MDN21WClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ZINC CARBONATEInactive
Code: EQR32Y7H0MClass: IACT
SODIUM XYLENESULFONATEInactive
Code: G4LZF950URClass: IACT
AMODIMETHICONE (800 CST)Inactive
Code: 363Z2T48P7Class: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KXClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)Inactive
Code: B16G315W7AClass: IACT
MAGNESIUM CARBONATE HYDROXIDEInactive
Code: YQO029V1L4Class: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPNClass: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFAClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
Code: R953O2RHZ5Class: ACTIBQuantity: 10 mg in 1 mL
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