NIOXIN PRO CLINICAL SCALP RECOVERY PURIFYING- pyrithione zinc shampoo

Nioxin PRO CLINICAL SCALP RECOVERY purifying by

Drug Labeling and Warnings

Nioxin PRO CLINICAL SCALP RECOVERY purifying by is a Otc medication manufactured, distributed, or labeled by Wella Operations US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Pyrithione zinc 1%

PURPOSE

Purpose

Anti-dandruff

INDICATIONS & USAGE

Uses

• Helps prevent recurrence of flaking and itching associated with dandruff.

WARNINGS

Warnings

For external use only.

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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• For best results use at least twice a week or as directed by a doctor.
• Massage on to wet scalp and hair. Rinse. Repeat if desired.

INACTIVE INGREDIENT

Inactive ingredients water, sodium laureth sulfate, PEG-3 distearate, sodium laureth-8 sulfate, sodium chloride, cocamidopropyl betaine, sodium benzoate, acrylates/steareth-20 methacrylate copolymer, magnesium laureth sulfate, magnesium laureth-8 sulfate, sodium oleth sulfate, fragrance, mentha arvensis leaf oil, citric acid, magnesium oleth sulfate, polyquaternium-10, sodium hydroxide, propylene glycol, benzoic acid, mentha piperita oil, sodium polynaphthalenesulfonate, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, geraniol, faex extract/yeast extract/extrait de levure, cellulose gum, biotin, lecithin, niacinamide, panthenol, tocopheryl acetate, ethoxydiglycol, methylisothiazolinone, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, potassium sorbate.

SPL UNCLASSIFIED SECTION

NIOXIN SCALP RECOVERY™

PURIFYING SHAMPOO

ANTI-DANDRUFF SHAMPOO THAT HELPS RELIEVE AND PREVENT SYMPTOMS OF DANDRUFF

WITH REGULAR USE

MADE IN USA WITH IMPORTED PARTS

Dist. Wella Operations US LLC, Calabasas, CA 91302

www.nioxin.com

QUESTIONS

Questions?

1-800-935-5273

PRINCIPAL DISPLAY PANEL

nioxin®

PRO CLINICAL

SCALP RECOVERY™

purifying shampoo

FOR ANTI-DANDRUFF

FOR ITCHY, FLAKY SCALP COMBATS DANDRUFF FROM THE 1 ST USE WITH PYRITHIONE ZINC.

CLINICALLY & DERMATOLOGICALLY TESTED

200 mL | 6.7 FL OZ

nioxin®

PRO CLINICAL

SCALP RECOVERY™

purifying shampoo

FOR ANTI-DANDRUFF

FOR ITCHY, FLAKY SCALP COMBATS DANDRUFF FROM THE 1 ST USE WITH PYRITHIONE ZINC.

CLINICALLY & DERMATOLOGICALLY TESTED

1L | 33.8 FL OZ

INGREDIENTS AND APPEARANCE

NIOXIN PRO CLINICAL SCALP RECOVERY PURIFYING 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82157-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
CITRIC ACID (UNII: 2968PHW8QP)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
METHYLPARABEN (UNII: A2I8C7HI9T)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
WATER (UNII: 059QF0KO0R)
POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
BIOTIN (UNII: 6SO6U10H04)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
GERANIOL (UNII: L837108USY)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ROSEMARY (UNII: IJ67X351P9)
SAGE (UNII: 065C5D077J)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CELLULOSE GUM (UNII: K679OBS311)
NIACINAMIDE (UNII: 25X51I8RD4)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
INOSITOL (UNII: 4L6452S749)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ)
SODIUM OLETH SULFATE (UNII: 3MX3FTR4XP)
PANTHENOL (UNII: WV9CM0O67Z)
CARAMEL (UNII: T9D99G2B1R)
TARTARIC ACID (UNII: W4888I119H)
ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PEG-3 DISTEARATE (UNII: 8420ECX438)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
MAGNESIUM OLETH SULFATE (UNII: LCQ4WP3DTL)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GLUCOSE (UNII: 5SL0G7R0OK)
LACTIC ACID (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-011-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2025
2	NDC: 82157-011-20	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	04/01/2025

Labeler - Wella Operations US LLC (117781338)