FDA.reportPublic FDA data

Nioxin PRO CLINICAL SCALP RECOVERY purifying

Manufacturer
Wella Operations US LLC
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:00

Label at a glance#

ProductNioxin PRO CLINICAL SCALP RECOVERY purifying
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%

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 - WHEN USING 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.
  • Massage on to wet scalp and hair. Rinse. Repeat if desired.

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

NIOXIN SCALP RECOVERY™

PURIFYING SHAMPOO

ANTI-DANDRUFF SHAMPOO THAT HELPS RELIEVE AND PREVENT SYMPTOMS OF DANDRUFF

WITH REGULAR USE

MADE IN USA WITH IMPORTED PARTS

Dist. Wella Operations US LLC, Calabasas, CA 91302

www.nioxin.com

OTC - QUESTIONS SECTION

Questions?

1-800-935-5273

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nioxin®

PRO CLINICAL

SCALP RECOVERY™

purifying shampoo

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

82157-011-20_front82157-011-20_front

82157-011-20_Back82157-011-20_Back

nioxin®

PRO CLINICAL

SCALP RECOVERY™

purifying shampoo

FOR ANTI-DANDRUFF

FOR ITCHY, FLAKY SCALP COMBATS DANDRUFF FROM THE 1 ST USE WITH PYRITHIONE ZINC.

CLINICALLY & DERMATOLOGICALLY TESTED

1L | 33.8 FL OZ

82157-011-10_Front82157-011-10_Front

82157-011-10_Back82157-011-10_Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1487080NIOXIN 1 % Medicated ShampooPSN2
209884zinc pyrithione 1 % Medicated ShampooPSN2
1487080zinc pyrithione 10 MG/ML Medicated Shampoo [Nioxin]SBD2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
1487080Nioxin 1 % Medicated ShampooSY2
1487080Nioxin 10 MG/ML ConditionerSY2
1487080Nioxin 10 MG/ML Medicated ShampooSY2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

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
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82157-011-10Nioxin PRO CLINICAL SCALP RECOVERY purifying1000 mL in 1 BOTTLE, PLASTICSHAMPOO10002
82157-011-20Nioxin PRO CLINICAL SCALP RECOVERY purifying200 mL in 1 BOTTLE, PLASTICSHAMPOO2002

Products#

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

DailyMed product names page 1 of 2 · 52 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-01182157-011-10, 82157-011-20

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 51 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURETH-8 SULFATEYP8U3694P0IACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
CITRIC ACID2968PHW8QPIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
METHYLPARABENA2I8C7HI9TIACT
BETULA PUBESCENS LEAF84SOH0O3OOIACT
HEXYL CINNAMAL7X6O37OK2IIACT
WATER059QF0KO0RIACT
POLYQUATERNIUM-10 (400 MPA.S AT 2%)HB1401PQFSIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
BIOTIN6SO6U10H04IACT
SODIUM HYDROXIDE55X04QC32IIACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
LINALOOL, (+/-)-D81QY6I88EIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
HEXAMETHYLINDANOPYRAN14170060ATIACT
GERANIOLL837108USYIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PROPYLPARABENZ8IX2SC1OHIACT
ROSEMARYIJ67X351P9IACT
SAGE065C5D077JIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CALCIUM PANTOTHENATE568ET80C3DIACT
SODIUM CHLORIDE451W47IQ8XIACT
INOSITOL4L6452S749IACT
CELLULOSE GUMK679OBS311IACT
NIACINAMIDE25X51I8RD4IACT
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
PANTHENOLWV9CM0O67ZIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
MAGNESIUM LAURETH SULFATEUKW9G007TZIACT
SODIUM OLETH SULFATE3MX3FTR4XPIACT
CARAMELT9D99G2B1RIACT
TARTARIC ACIDW4888I119HIACT
MAGNESIUM LAURETH-8 SULFATE2OTJ9LF5UAIACT
ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMEREPA1872R1NIACT

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 · 2 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): 82157-011-10
ndc (package): 82157-011-20
ndc (product): 82157-011
ndc11 (package): 82157001110
ndc11 (package): 82157001120
spl id: 44746d42-41d8-e499-e063-6394a90aac2d
spl set id: 316c61e9-7cdf-a548-e063-6294a90ab7c3
nioxin PRO CLINICAL SCALP RECOVERYPYRITHIONE ZINCWella Operations US LLC31bf4f7f-8228-7433-e063-6394a90a2f5f2025-11-25WarningsExact identifier
ndc (package): 82157-011-20
ndc11 (package): 82157001120

Reported adverse events (FAERS/openFDA)#

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