FDA.reportPublic FDA data

nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum

Manufacturer
Wella Operations US LLC
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:40:43

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, 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

NIOXIN SCALP RECOVERY™

SCALP SOOTHING SERUM

WITH PYRITHIONE ZINC IS A LEAVE-ON TREATMENT THAT HELPS RELIEVE DANDRUFF.

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

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)

82157-009-01_F82157-009-01_F82157-009-01_B82157-009-01_B

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
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 · 58 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-00982157-009-01, 82157-009-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 57 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BHT1P9D0Z171KIACT
ALPHA-ISOMETHYL IONONE9XP4LC555BIACT
LINALOOL, (+/-)-D81QY6I88EIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
POLYSORBATE 60CAL22UVI4MIACT
LIMONENE, (+/-)-9MC3I34447IACT
NIACINAMIDE25X51I8RD4IACT
PROPYLPARABENZ8IX2SC1OHIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
HEXYL CINNAMAL7X6O37OK2IIACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
SILICAETJ7Z6XBU4IACT
SODIUM PHOSPHATESE337SVY37IACT
SODIUM BENZOATEOJ245FE5EUIACT
INOSITOL4L6452S749IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PEG-2MV46Y6OJ5QBIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
CARAMELT9D99G2B1RIACT
METHYLPARABENA2I8C7HI9TIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL STEARATE230OU9XXE4IACT
BIOTIN6SO6U10H04IACT
SAGE065C5D077JIACT
BETULA PUBESCENS LEAF84SOH0O3OOIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
CETYL ALCOHOL936JST6JCNIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PANTHENOLWV9CM0O67ZIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
DMDM HYDANTOINBYR0546TOWIACT
MALTODEXTRIN7CVR7L4A2DIACT

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
447452aa-4647-6289-e063-6294a90ae17b29af67c5-2bf8-80f5-e063-6294a90a56542025-11-25WarningsExact identifier
spl id: 447452aa-4647-6289-e063-6294a90ae17b
spl set id: 29af67c5-2bf8-80f5-e063-6294a90a5654

Reported adverse events (FAERS/openFDA)#

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