NIOXIN SCALP RECOVERY SOOTHING SERUM- pyrithione zinc lotion/shampoo

Nioxin Scalp Recovery by

Drug Labeling and Warnings

Nioxin Scalp Recovery by is a Otc medication manufactured, distributed, or labeled by The Wella Corporation, Coty US LLC, Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione Zinc 0.1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

• helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Warnings

For external use only.

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• condition worsens or does not improve after regular use of this product as directed.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply to affected areas one to four times daily or as directed by a doctor.

Inactive ingredients

water, stearamidopropyl dimethylamine, cetyl alcohol, hydroxyethylcellulose, quaternium-18, benzyl alcohol, phenoxyethanol, stearyl alcohol, PEG-2M, dimethicone, cetearyl alcohol, methylparaben, propylparaben, fragrance, glyceryl stearate, oleyl alcohol, citric acid, polysorbate 60, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, yeast extract, camellia sinensis leaf extract, lecithin, PPG-26-buteth-26, saccharomyces/magnesium ferment, dimethyl isosorbide, carnitine HCL, PEG/PPG-18/18 dimethicone, ethoxydiglycol, oryza sativa (rice) bran, PEG-40 hydrogenated castor oil, biotin/folic acid/cyanocobalamin/niacinamide/pantothenic acid/pyridoxine/riboflavin/thiamine/yeast polypeptides, saccharomyces/iron ferment, saccharomyces/copper ferment, saccharomyces/silicon ferment, saccharomyces/zinc ferment, acacia senegal gum, ubiquinone.

Questions?

1-800-935-5273

SPL UNCLASSIFIED SECTION

Dist. by
THE WELLA CORPORATION,
WOODLAND HILLS, CA 91367

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

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)

INGREDIENTS AND APPEARANCE

NIOXIN SCALP RECOVERY   SOOTHING SERUM
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69282-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.1 g  in 100 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)
POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)
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)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
RICE BRAN (UNII: R60QEP13IC)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
ACACIA (UNII: 5C5403N26O)
UBIDECARENONE (UNII: EJ27X76M46)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69282-006-50	1 in 1 CARTON	07/01/2016
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 69282-006-10	1 in 1 CARTON	07/01/2016
2		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/01/2016

Labeler - The Wella Corporation (829413157)

Registrant - Coty US LLC (039056361)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	manufacture(69282-006)