nioxin PRO CLINICAL SCALP RECOVERY SYSTEM FOR ANTI-DANDRUFF

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, kdc/one Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIOXIN PRO CLINICAL SCALP RECOVERY- pyrithione zinc 
Wella Operations US LLC

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nioxin PRO CLINICAL SCALP RECOVERY SYSTEM FOR ANTI-DANDRUFF

Drug Facts

Active ingredient

Pyrithione zinc 1% (purifying shampoo)

Pyrithione zinc 0.5% (moisturizing conditioner)

Pyrithione zinc 0.1% (scalp soothing serum)

Purpose

Anti-dandruff

Uses

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

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.

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.

PURIFYING SHAMPOO

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.

MOISTURIZING CONDITIONER

Inactive ingredients water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, dimethicone, glutamic acid, benzyl alcohol, phenoxyethanol, fragrance, methylparaben, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, propylene glycol, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, sodium polynaphthalenesulfonate, geraniol, DMDM hydantoin, cellulose gum, yeast extract, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, maltodextrin, glucose, propylparaben, lactic acid, sodium benzoate, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, achillea millefolium extract, betula alba leaf extract, potassium sorbate, inositol, calcium pantothenate, tartaric acid, caramel.

SCALP SOOTHING SERUM

Inactive ingredients water, cetyl alcohol, stearamidopropyl dimethylamine, stearyl alcohol, distearyldimonium chloride, hydroxyethylcellulose, benzyl alcohol, phenoxyethanol, PEG-2M, dimethicone, fragrance, cetearyl alcohol, methylparaben, glyceryl stearate, oleyl alcohol, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, polysorbate 60, propylene glycol, camellia sinensis leaf extract, linalool, hexyl cinnamal, limonene, silica, geraniol, benzyl salicylate, alpha-isomethyl ionone, sodium polynaphthalenesulfonate, yeast extract, disodium phosphate, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, DMDM hydantoin, maltodextrin, cellulose gum, sodium phosphate, BHT, glucose, propylparaben, lactic acid, sodium benzoate, betula alba leaf extract, achillea millefolium extract, utica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, caramel, tartaric acid

Questions?

1-800-935-5273

MADE IN USA WITH IMPORTED PARTS

Dist. Wella Operations US LLC,

Calabasas, CA 91302

www.nioxin.com

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)

NIOXIN PRO CLINICAL SCALP RECOVERY 
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82157-010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-010-99	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	12/19/2024	12/31/2025

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 PURIFYING 
pyrithione zinc shampoo

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-007-20	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	12/19/2024	12/31/2025

Part 2 of 3

NIOXIN PRO CLINICAL SCALP RECOVERY MOISTURIZING CONDITIONER 
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC: 82157-008
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
SAGE (UNII: 065C5D077J)
DMDM HYDANTOIN (UNII: BYR0546TOW)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID (UNII: 2968PHW8QP)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CARAMEL (UNII: T9D99G2B1R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PANTHENOL (UNII: WV9CM0O67Z)
INOSITOL (UNII: 4L6452S749)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CELLULOSE GUM (UNII: K679OBS311)
GLUCOSE (UNII: 5SL0G7R0OK)
SODIUM BENZOATE (UNII: OJ245FE5EU)
DIMETHICONE (UNII: 92RU3N3Y1O)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
NIACINAMIDE (UNII: 25X51I8RD4)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
LACTIC ACID (UNII: 33X04XA5AT)
BIOTIN (UNII: 6SO6U10H04)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLPARABEN (UNII: A2I8C7HI9T)
ROSEMARY (UNII: IJ67X351P9)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-008-20	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	12/19/2024	12/31/2025

Part 3 of 3

NIOXIN PRO CLINICAL SCALP RECOVERY SCALP SOOTHING SERUM 
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC: 82157-009
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
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CARAMEL (UNII: T9D99G2B1R)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
GLUCOSE (UNII: 5SL0G7R0OK)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
POLYSORBATE 60 (UNII: CAL22UVI4M)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
BHT (UNII: 1P9D0Z171K)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
CITRIC ACID (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
GERANIOL (UNII: L837108USY)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
PANTHENOL (UNII: WV9CM0O67Z)
TARTARIC ACID (UNII: W4888I119H)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALPHA-ISOMETHYL IONONE (UNII: 9XP4LC555B)
SILICA (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
CELLULOSE GUM (UNII: K679OBS311)
LACTIC ACID (UNII: 33X04XA5AT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ROSEMARY (UNII: IJ67X351P9)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
PEG-2M (UNII: V46Y6OJ5QB)
SODIUM PHOSPHATE (UNII: SE337SVY37)
INOSITOL (UNII: 4L6452S749)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
BIOTIN (UNII: 6SO6U10H04)
SAGE (UNII: 065C5D077J)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82157-009-01	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	12/19/2024	12/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/19/2024	12/31/2025

Labeler - Wella Operations US LLC (117781338)

Establishment
Name	Address	ID/FEI	Business Operations
kdc/one Chatsworth, Inc.		118542196	manufacture(82157-010)

Revised: 11/2025

Document Id: 44745c64-ee20-6546-e063-6294a90a4d48

34390-5

Set id: 29bcee0c-69d6-e7f3-e063-6394a90aef3c

Version: 2

Effective Time: 20251125