NDC Code(s) : 37000-739-50, 37000-739-20, 37000-739-10
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 LOTION/SHAMPOO
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-739
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 ZINC1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE(UNII: BPV390UAP0)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
COCO MONOETHANOLAMIDE(UNII: C80684146D)
ZINC CARBONATE(UNII: EQR32Y7H0M)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
DIMETHICONE(UNII: 92RU3N3Y1O)
CETYL ALCOHOL(UNII: 936JST6JCN)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)(UNII: B16G315W7A)
SODIUM XYLENESULFONATE(UNII: G4LZF950UR)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM BENZOATE(UNII: OJ245FE5EU)
DMDM HYDANTOIN(UNII: BYR0546TOW)
PEPPERMINT OIL(UNII: AV092KU4JH)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
MENTHA ARVENSIS LEAF OIL(UNII: 1AEY1M553N)
MAGNESIUM CARBONATE HYDROXIDE(UNII: YQO029V1L4)
BENZYL ALCOHOL(UNII: LKG8494WBH)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-739-5050 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2011
2NDC:37000-739-20200 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2011
3NDC:37000-739-101000 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
SHAMPOO

MEDICATING
CLEANSER

100% FLAKE FREE
ELIMINATION OF
VISIBLE FLAKES WITH
REGULAR USE

REDUCES HAIR BREAKAGE
FROM SCALP ITCHING

HELPS SOOTHE DRY SCALP
OVER TIME

99312360

1 L (3.38 FL OZ)

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label