FDA.reportPublic FDA data

nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum

Manufacturer
The Wella Corporation
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:32

Label at a glance#

Productnioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Pyrithione zinc 0.1%

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

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

INACTIVE INGREDIENT SECTION

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

NIOXIN SCALP RECOVERY™

SCALP SOOTHING SERUM

LEAVE-ON TREATMENT THAT RELIEVES DANDRUFF SYMPTOMS, SUCH AS ITCHING AND FLAKING 1
1WITH REGULAR USE OF THE SCALP RECOVERY PURIFYING SHAMPOO.

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 TM

scalp soothing serum

FOR ANTI-DANDRUFF

FOR ITCHY FLAKY SCALP

COMBATS DANDRUFF FROM THE 1ST USE

WITH PYRITHIONE ZINC

CLINICALLY & DERMATOLOGICALLY TESTED

100 mL | 3.3 FL OZ

82157-013-01_Front82157-013-01_Front

82157-013-01_Back82157-013-01_Back

82157-013-01_FOCA82157-013-01_FOCA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82157-013-01nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum100 mL in 1 BOTTLE, PLASTICLOTION1001
82157-013-10nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum100 mL in 1 BOTTLE, PLASTICLOTION1001
82157-013-10nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82157-013NIOXIN PRO CLINICAL SCALP RECOVERY SCALP SOOTHING SERUM (PYRITHIONE ZINC) LOTION [THE WELLA CORPORATION]1Current NDC, 3 package rows20250406_31af9365-e1a3-7203-e063-6294a90a8ade.zip

Products#

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

DailyMed product names page 1 of 2 · 62 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-01382157-013-01, 82157-013-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 61 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
CETEARYL ALCOHOL2DMT128M1SIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
LIMONENE, (+/-)-9MC3I34447IACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
BIOTIN6SO6U10H04IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PANTHENOLWV9CM0O67ZIACT
CARAMELT9D99G2B1RIACT
POLYSORBATE 60CAL22UVI4MIACT
CITRUS AURANTIUM PEEL OIL9TLV70SV6IIACT
TRIMETHYLBENZENEPROPANOL7S411YY2VYIACT
GLUCOSE5SL0G7R0OKIACT
INOSITOL4L6452S749IACT
DISODIUM PHOSPHATE22ADO53M6FIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
BETULA ALBA LEAF84SOH0O3OOIACT
HEXAMETHYLINDANOPYRAN14170060ATIACT
GERANIOLL837108USYIACT
ALPHA-ISOMETHYL IONONE9XP4LC555BIACT
NIACINAMIDE25X51I8RD4IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CELLULOSE GUMK679OBS311IACT
ROSEMARYIJ67X351P9IACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES2JU6ZH6GREIACT
LINALYL ACETATE5K47SSQ51GIACT
CITRUS LIMON (LEMON) PEEL OILI9GRO824LLIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
SODIUM PHOSPHATESE337SVY37IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serumPYRITHIONE ZINCThe Wella Corporation31af9365-e1a3-7203-e063-6294a90a8ade2025-03-31WarningsExact identifier
ndc (package): 82157-013-01
ndc (package): 82157-013-10
ndc (product): 82157-013
ndc11 (package): 82157001301
ndc11 (package): 82157001310
spl id: 31af9365-e1a4-7203-e063-6294a90a8ade
spl set id: 31af9365-e1a3-7203-e063-6294a90a8ade

Reported adverse events (FAERS/openFDA)#

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