NDC Code(s) : 37000-733-50, 37000-733-10
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nioxin Scalp Recovery Pyrithione Zinc LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-733
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 ZINC0.97 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
STEARAMIDOPROPYL DIMETHYLAMINE(UNII: K7VEI00UFR)
CETYL ALCOHOL(UNII: 936JST6JCN)
QUATERNIUM-18(UNII: O7757NO1VL)
BENZYL ALCOHOL(UNII: LKG8494WBH)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
DIMETHICONE(UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
OLEYL ALCOHOL(UNII: 172F2WN8DV)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POLYSORBATE 60(UNII: CAL22UVI4M)
PEPPERMINT OIL(UNII: AV092KU4JH)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
MENTHA ARVENSIS LEAF OIL(UNII: 1AEY1M553N)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
DIMETHYL ISOSORBIDE(UNII: SA6A6V432S)
CARNITINE CHLORIDE(UNII: F64264D63N)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
RICE BRAN(UNII: R60QEP13IC)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
BIOTIN(UNII: 6SO6U10H04)
FOLIC ACID(UNII: 935E97BOY8)
CYANOCOBALAMIN(UNII: P6YC3EG204)
NIACINAMIDE(UNII: 25X51I8RD4)
PANTOTHENIC ACID(UNII: 19F5HK2737)
PYRIDOXINE(UNII: KV2JZ1BI6Z)
RIBOFLAVIN(UNII: TLM2976OFR)
THIAMINE(UNII: X66NSO3N35)
ACACIA(UNII: 5C5403N26O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-733-501 in 1 CARTON 01/01/2011
150 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:37000-733-10100 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358H 01/01/2011 07/01/2018

PRINCIPAL DISPLAY PANEL

NIOXIN ®
SCALP RECOVERY ®

For a dry, itchy scalp

PYRITHIONE ZINC
DANDRUFF AND
SEBORRHEIC
DERMATITIS
TREATMENT

SOOTHING
SERUM

100% FLAKE FREE
ELIMINATION OF
VISIBLE FLAKES WITH
REGULAR USE*

100 mL (3.38 FL OZ)

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton