FDA.reportPublic FDA data

nioxin PRO CLINICAL SCALP RECOVERY

Manufacturer
Wella Operations US LLC
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:18:01

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, 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.

OTC - QUESTIONS SECTION

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

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 OZ200 mL | 6.7 FL OZ100 mL | 3.3 FL OZ

82157-014_FOCA82157-014_FOCA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1593569NIOXIN 0.5 % Medicated ConditionerPSN3
1487080NIOXIN 1 % Medicated ShampooPSN3
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN3
209884zinc pyrithione 1 % Medicated ShampooPSN3
1487080zinc pyrithione 10 MG/ML Medicated Shampoo [Nioxin]SBD3
1593569zinc pyrithione 5 MG/ML Medicated Shampoo [Nioxin]SBD3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD3
1593569Nioxin 0.5 % Medicated ConditionerSY3
1593569Nioxin 0.5 % Medicated ShampooSY3
1487080Nioxin 1 % Medicated ShampooSY3
1487080Nioxin 10 MG/ML ConditionerSY3
1487080Nioxin 10 MG/ML Medicated ShampooSY3
1593569Nioxin 5 MG/ML Medicated ShampooSY3
1043014zinc pyrithione 0.5 % Medicated ShampooSY3
209884zinc pyrithione 1 % Medicated ConditionerSY3
209884zinc pyrithione 1 % Medicated ShampooSY3

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
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82157-011-20nioxin PRO CLINICAL SCALP RECOVERY200 mL in 1 BOTTLE, PLASTICSHAMPOO200 mL1 g in 100mL3
82157-012-20nioxin PRO CLINICAL SCALP RECOVERY200 mL in 1 BOTTLE, PLASTICLOTION200 mL0.5 g in 100mL3
82157-014-99nioxin PRO CLINICAL SCALP RECOVERY1 in 1 CARTONKIT13
82157-015-01nioxin PRO CLINICAL SCALP RECOVERY100 mL in 1 BOTTLE, PLASTICLOTION100 mL0.1 g in 100mL3

Products#

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

DailyMed product names page 1 of 2 · 79 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-01482157-014-99
82157-01282157-012-20
82157-01182157-011-20
82157-01582157-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 156 matching rows.

Name, UNII, Kind table
NameUNIIKind
INOSITOL4L6452S749IACT
CELLULOSE GUMK679OBS311IACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
CITRIC ACID2968PHW8QPIACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
HEXYL CINNAMAL7X6O37OK2IIACT
GERANIOLL837108USYIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
WATER059QF0KO0RIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
LACTIC ACID33X04XA5ATIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
CARAMELT9D99G2B1RIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
PANTHENOLWV9CM0O67ZIACT
GLUCOSE5SL0G7R0OKIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SAGE065C5D077JIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HEXAMETHYLINDANOPYRAN14170060ATIACT
BIOTIN6SO6U10H04IACT
CETYL ALCOHOL936JST6JCNIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
GLUTAMIC ACID3KX376GY7LIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
LIMONENE, (+/-)-9MC3I34447IACT
ROSEMARYIJ67X351P9IACT
BETULA ALBA LEAF84SOH0O3OOIACT
TARTARIC ACIDW4888I119HIACT
CALCIUM PANTOTHENATE568ET80C3DIACT

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nioxin PRO CLINICAL SCALP RECOVERY purifyingPYRITHIONE ZINCWella Operations US LLC316c61e9-7cdf-a548-e063-6294a90ab7c32025-11-25WarningsExact identifier
ndc (package): 82157-011-20
ndc (product): 82157-011
ndc11 (package): 82157001120
nioxin PRO CLINICAL SCALP RECOVERY moisturizing conditionerPYRITHIONE ZINCWella Operations US LLC31a715eb-7be8-8bad-e063-6394a90aba792025-11-25WarningsExact identifier
ndc (package): 82157-012-20
ndc (product): 82157-012
ndc11 (package): 82157001220
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31ce9b5c-d388-8e1d-e063-6294a90a2fb82025-11-25WarningsExact identifier
ndc (package): 82157-015-01
ndc (product): 82157-015
ndc11 (package): 82157001501
nioxin PRO CLINICAL SCALP RECOVERYPYRITHIONE ZINCWella Operations US LLC31bf4f7f-8228-7433-e063-6394a90a2f5f2025-11-25WarningsExact identifier
ndc (package): 82157-011-20
ndc (package): 82157-012-20
ndc (package): 82157-015-01
ndc (package): 82157-014-99
ndc (product): 82157-014
ndc11 (package): 82157001501
ndc11 (package): 82157001499
ndc11 (package): 82157001220
ndc11 (package): 82157001120
spl id: 4474c221-ae62-1441-e063-6294a90a30f9
spl set id: 31bf4f7f-8228-7433-e063-6394a90a2f5f

Reported adverse events (FAERS/openFDA)#

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