NIOXIN PRO CLINICAL SCALP RECOVERY- pyrithione zinc kit

nioxin PRO CLINICAL SCALP RECOVERY by

Drug Labeling and Warnings

nioxin PRO CLINICAL SCALP RECOVERY 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% (purifying shampoo)

Pyrithione zinc 0.5% (moisturizing conditioner)

Pyrithione zinc 0.1% (scalp soothing serum)

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

PURIFYING SHAMPOO

• 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.

MOISTURIZING CONDITIONER

• For best results use at least twice a week or as directed by a doctor.
• Apply to wet scalp and hair, leave for 1-3 minutes. Rinse well.

SCALP SOOTHING SERUM

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

INACTIVE INGREDIENT

PURIFYING SHAMPOO

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.

MOISTURIZING CONDITIONER

Inactive ingredients water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, phenoxyethanol, dimethicone, glutamic acid, fragrance, mentha arvensis leaf oil, citric acid, propylene glycol, mentha piperita oil, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, sodium polynaphthalenesulfonate, geraniol, faex extract/yeast extract/extrait de levure, cellulose gum, biotin, lecithin, niacinamide, panthenol, tocopheryl acetate, ethoxydiglycol, methylisothiazolinone, methylparaben, glucose, propylparaben, lactic acid, sodium benzoate, 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, calcium pantothenate, inositol, tartaric acid, caramel.

SCALP SOOTHING SERUM

Inactive ingredients water, phenoxyethanol, cetyl alcohol, stearamidopropyl dimethylamine, stearyl alcohol, hydroxyethylcellulose, distearyldimonium chloride, PEG-2M, dimethicone, fragrance, cetearyl alcohol, mentha arvensis leaf oil, glyceryl stearate, oleyl alcohol, citric acid, polysorbate 60, propylene glycol, mentha piperita oil, camellia sinensis leaf extract, linalool, hexyl cinnamal, hexamethylindanopyran, limonene, silica, geraniol, faex extract/yeast extract/extrait de levure, tetramethyl acetyloctahydronaphthalenes, benzyl salicylate, sodium polynaphthalenesulfonate, alpha-isomethyl ionone, disodium phosphate, biotin, lecithin, niacinamide, panthenol, tocopheryl acetate, citrus aurantium peel oil, linalyl acetate, citrus limon peel oil, trimethylbenzenepropanol, ethoxydiglycol, cellulose gum, sodium phosphate, BHT, methylparaben, glucose, propylparaben, methylisothiazolinone, lactic acid, sodium benzoate, 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, calcium pantothenate, inositol, tartaric acid, caramel.

QUESTIONS

Questions?

1-800-935-5273

SPL UNCLASSIFIED SECTION

SCALP RECOVERY™ SYSTEM

An anti-dandruff system, that helps to restore the natural scalp balance and relieve dandruff symptoms, such as itching and flaking².

MADE IN USA WITH IMPORTED PARTS

Dist. Wella Operations US LLC,

Calabasas, CA 91302
www.nioxin.com

PRINCIPAL DISPLAY PANEL

nioxin® PRO CLINICAL

SCALP RECOVERY™ SYSTEM

FOR ANTI-DANDRUFF

FOR ITCHY, FLAKY SCALP

WITH PYRITHIONE ZINC

FOR ALL HAIR TYPES

CLINICALLY & DERMATOLOGICALLY TESTED

SCALP RECOVERY™ purifying shampoo	SCALP RECOVERY™ moisturizing conditioner	SCALP RECOVERY™ scalp soothing serum
200 mL | 6.7 FL OZ	200 mL | 6.7 FL OZ	100 mL | 3.3 FL OZ

INGREDIENTS AND APPEARANCE

NIOXIN PRO CLINICAL SCALP RECOVERY 
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82157-014

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-014-99	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	04/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	200 mL
Part 2	1 BOTTLE, PLASTIC	200 mL
Part 3	1 BOTTLE, PLASTIC	100 mL

Part 1 of 3

NIOXIN PRO CLINICAL SCALP RECOVERY MOISTURIZING CONDITIONER 
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC: 82157-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
INOSITOL (UNII: 4L6452S749)
CELLULOSE GUM (UNII: K679OBS311)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID (UNII: 2968PHW8QP)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
GERANIOL (UNII: L837108USY)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
WATER (UNII: 059QF0KO0R)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
LACTIC ACID (UNII: 33X04XA5AT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
CARAMEL (UNII: T9D99G2B1R)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
PANTHENOL (UNII: WV9CM0O67Z)
GLUCOSE (UNII: 5SL0G7R0OK)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SAGE (UNII: 065C5D077J)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
BIOTIN (UNII: 6SO6U10H04)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
GLUTAMIC ACID (UNII: 3KX376GY7L)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
ROSEMARY (UNII: IJ67X351P9)
BETULA ALBA LEAF (UNII: 84SOH0O3OO)
TARTARIC ACID (UNII: W4888I119H)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-012-20	200 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

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

Part 2 of 3

NIOXIN PRO CLINICAL SCALP RECOVERY PURIFYING 
pyrithione zinc shampoo

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-011-20	200 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

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

Part 3 of 3

NIOXIN PRO CLINICAL SCALP RECOVERY SCALP SOOTHING SERUM 
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC: 82157-015
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
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
BIOTIN (UNII: 6SO6U10H04)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
LINALYL ACETATE (UNII: 5K47SSQ51G)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ROSEMARY (UNII: IJ67X351P9)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SAGE (UNII: 065C5D077J)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
PEG-2M (UNII: V46Y6OJ5QB)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
CITRUS AURANTIUM PEEL OIL (UNII: 9TLV70SV6I)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
LACTIC ACID (UNII: 33X04XA5AT)
CITRIC ACID (UNII: 2968PHW8QP)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SILICA (UNII: ETJ7Z6XBU4)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PANTHENOL (UNII: WV9CM0O67Z)
INOSITOL (UNII: 4L6452S749)
CARAMEL (UNII: T9D99G2B1R)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GERANIOL (UNII: L837108USY)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
NIACINAMIDE (UNII: 25X51I8RD4)
CELLULOSE GUM (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
BETULA ALBA LEAF (UNII: 84SOH0O3OO)
TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
BHT (UNII: 1P9D0Z171K)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
METHYLPARABEN (UNII: A2I8C7HI9T)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
GLUCOSE (UNII: 5SL0G7R0OK)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
ALPHA-ISOMETHYL IONONE (UNII: 9XP4LC555B)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-015-01	100 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	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)