FDA.reportPublic FDA data

nioxin PRO CLINICAL SCALP RECOVERY

Manufacturer
Wella Operations US LLC | kdc/one Chatsworth, Inc.
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:40:43

Label at a glance#

Productnioxin PRO CLINICAL SCALP RECOVERY
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Pyrithione zinc 1% (purifying shampoo)

Pyrithione zinc 0.5% (moisturizing conditioner)

Pyrithione zinc 0.1% (scalp soothing serum)

OTC - PURPOSE SECTION

Purpose

Anti-dandruff

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

Questions?

1-800-935-5273

SPL UNCLASSIFIED SECTION

MADE IN USA WITH IMPORTED PARTS

Dist. Wella Operations US LLC,

Calabasas, CA 91302

www.nioxin.com

PACKAGE LABEL.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)

82157-010-99_KIT82157-010-99_KIT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 75 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-01082157-010-99
82157-00782157-007-20
82157-00882157-008-20
82157-00982157-009-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 154 matching rows.

Name, UNII, Kind table
NameUNIIKind
PANTHENOLWV9CM0O67ZIACT
MAGNESIUM LAURETH-8 SULFATE2OTJ9LF5UAIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
TARTARIC ACIDW4888I119HIACT
BENZOIC ACID8SKN0B0MIMIACT
SAGE065C5D077JIACT
MAGNESIUM OLETH SULFATELCQ4WP3DTLIACT
SODIUM BENZOATEOJ245FE5EUIACT
PEG-3 DISTEARATE8420ECX438IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BETULA PUBESCENS LEAF84SOH0O3OOIACT
SODIUM CHLORIDE451W47IQ8XIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
GLUCOSE5SL0G7R0OKIACT
SODIUM LAURETH-8 SULFATEYP8U3694P0IACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
BIOTIN6SO6U10H04IACT
ROSEMARYIJ67X351P9IACT
URTICA DIOICA LEAFX6M0DRN46QIACT
SODIUM OLETH SULFATE3MX3FTR4XPIACT
WATER059QF0KO0RIACT
MALTODEXTRIN7CVR7L4A2DIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CITRIC ACID2968PHW8QPIACT
INOSITOL4L6452S749IACT
LIMONENE, (+/-)-9MC3I34447IACT
BENZYL ALCOHOLLKG8494WBHIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
HEXYL CINNAMAL7X6O37OK2IIACT
GERANIOLL837108USYIACT
NIACINAMIDE25X51I8RD4IACT
LACTIC ACID33X04XA5ATIACT
ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMEREPA1872R1NIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
44745c64-ee20-6546-e063-6294a90a4d4829bcee0c-69d6-e7f3-e063-6394a90aef3c2025-11-25WarningsExact identifier
spl id: 44745c64-ee20-6546-e063-6294a90a4d48
spl set id: 29bcee0c-69d6-e7f3-e063-6394a90aef3c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.