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 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, acrylates/steareth-20 methacrylate copolymer, magnesium laureth-8 sulfate, magnesium laureth sulfate, sodium oleth sulfate, fragrance, sodium benzoate, citric acid, DMDM hydantoin, mentha arvensis leaf oil, mentha piperita (peppermint) oil, magnesium oleth sulfate, sodium hydroxide, polyquaternium-10, propylene glycol, benzoic acid, linalool, hexyl cinnamal, camellia sinensis leaf extract, sodium polynaphthalenesulfonate, benzyl alcohol, limonene, geraniol, cellulose gum, yeast extract, niacinamide, tocopheryl acetate, panthenol, biotin, lecithin, ethoxydiglycol, maltodextrin, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, urtica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.

SPL UNCLASSIFIED SECTION

NIOXIN SCALP RECOVERY™

PURIFYING SHAMPOO

HELPS PREVENT AND RELIEVE THE SYMPTOMS OF DANDRUFF, SUCH AS ITCHING, AND FLAKING.*

*VISIBLE FLAKES, 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)

INGREDIENTS AND APPEARANCE

NIOXIN PRO CLINICAL SCALP RECOVERY PURIFYING 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82157-007
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
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA)
PANTHENOL (UNII: WV9CM0O67Z)
TARTARIC ACID (UNII: W4888I119H)
BENZOIC ACID (UNII: 8SKN0B0MIM)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
GLUCOSE (UNII: 5SL0G7R0OK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SAGE (UNII: 065C5D077J)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
INOSITOL (UNII: 4L6452S749)
GERANIOL (UNII: L837108USY)
NIACINAMIDE (UNII: 25X51I8RD4)
LACTIC ACID (UNII: 33X04XA5AT)
ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PEG-3 DISTEARATE (UNII: 8420ECX438)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
MAGNESIUM OLETH SULFATE (UNII: LCQ4WP3DTL)
PEPPERMINT OIL (UNII: AV092KU4JH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CELLULOSE GUM (UNII: K679OBS311)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID (UNII: 2968PHW8QP)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BIOTIN (UNII: 6SO6U10H04)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
CARAMEL (UNII: T9D99G2B1R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
ROSEMARY (UNII: IJ67X351P9)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ)
SODIUM OLETH SULFATE (UNII: 3MX3FTR4XP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-007-20	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/19/2024
2	NDC: 82157-007-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/19/2024

Labeler - Wella Operations US LLC (117781338)