FDA.reportPublic FDA data

nioxin PRO CLINICAL SCALP RECOVERY moisturizing conditioner

Manufacturer
Wella Operations US LLC
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:40:48

Label at a glance#

Productnioxin PRO CLINICAL SCALP RECOVERY moisturizing conditioner
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Pyrithione zinc 0.5%

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

  • 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.

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

Questions?

1-800-935-5273

SPL UNCLASSIFIED SECTION

NIOXIN SCALP RECOVERY™

MOISTURIZING CONDITIONER

HELPS TO REDUCE DANDRUFF AND PROVIDE SMOOTHNESS. AS PART OF A COMPLETE SCALP AND HAIR CARE SYSTEM, THIS CONDITIONER LEAVES HAIR NOURISHED, MOISTURIZED AND PROVIDES RESILIENCE AGAINST BREAKAGE.

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™

moisturizing conditioner

FOR ANTI-DANDRUFF

FOR ITCHY, FLAKY SCALP

COMBATS DANDRUFF FROM THE 1 ST USE

WITH PYRITHIONE ZINC

CLINICALLY & DERMATOLOGICALLY TESTED

200 mL (6.7 FL OZ)

82157-008-10_F82157-008-10_F82157-008-20_F82157-008-20_F82157-008-10_B82157-008-10_B82157-008-20_B82157-008-20_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
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 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-00882157-008-20, 82157-008-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
NIACINAMIDE25X51I8RD4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLUTAMIC ACID3KX376GY7LIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
CETYL ALCOHOL936JST6JCNIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PANTHENOLWV9CM0O67ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SAGE065C5D077JIACT
CARAMELT9D99G2B1RIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
BENZYL ALCOHOLLKG8494WBHIACT
ROSEMARYIJ67X351P9IACT
LACTIC ACID33X04XA5ATIACT
MALTODEXTRIN7CVR7L4A2DIACT
GERANIOLL837108USYIACT
DMDM HYDANTOINBYR0546TOWIACT
BIOTIN6SO6U10H04IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
INOSITOL4L6452S749IACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
CITRIC ACID2968PHW8QPIACT
LINALOOL, (+/-)-D81QY6I88EIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
LIMONENE, (+/-)-9MC3I34447IACT
BETULA PUBESCENS LEAF84SOH0O3OOIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
CELLULOSE GUMK679OBS311IACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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
44744c86-b3a3-498c-e063-6294a90a86f929ae4f3f-4d77-8099-e063-6394a90a89f02025-11-25WarningsExact identifier
spl id: 44744c86-b3a3-498c-e063-6294a90a86f9
spl set id: 29ae4f3f-4d77-8099-e063-6394a90a89f0

Reported adverse events (FAERS/openFDA)#

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