NDC Code(s) : 36800-281-15, 36800-281-32
Packager : Topco Associates LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DandruffPyrithione zinc SHAMPOO
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-281
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC(UNII: R953O2RHZ5)
(PYRITHIONE ZINC - UNII:R953O2RHZ5) 		PYRITHIONE ZINC10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ZINC CARBONATE(UNII: EQR32Y7H0M)
SODIUM XYLENESULFONATE(UNII: G4LZF950UR)
AMODIMETHICONE (1300 CST)(UNII: 3V7U636DWN)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
SODIUM BENZOATE(UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)(UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE(UNII: YQO029V1L4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ALMOND OIL(UNII: 66YXD4DKO9)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:36800-281-15420 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/05/2002
2NDC:36800-281-32370 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M032 05/28/2002

LABELER - Topco Associates LLC(006935977)

REGISTRANT - Consumer Product Partners, LLC(119091520)

Establishment
Name Address ID/FEI Business Operations
Consumer Product Partners, LLC 119091520 manufacture(36800-281)

Establishment
Name Address ID/FEI Business Operations
Consumer Product Partners, LLC 119091514 manufacture(36800-281)

PRINCIPAL DISPLAY PANEL

TopCare beauty

DRY SCALP

GENTLE DANDRUFF SHAMPOO

with Pyrithione Zinc

Compare to HEAD & SHOULDERS​​ ®*

with Almond Oil

Helps prevent flakes

Moisture balancing for dry scalp relief

Gentle enough for everyday use

12.5 FL OZ (270mL)

mm01