FDA.reportPublic FDA data

Nioxin Scalp Recovery Anti-Dandruff System

Manufacturer
Wella Operations US LLC
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:40:46

Label at a glance#

ProductNioxin Scalp Recovery Anti-Dandruff System
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% (Medicating Cleanser)

Pyrithione zinc 0.5% (Moisturizing Conditioner)

Pyrithione zinc 0.1% (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

MEDICATING CLEANSER

  • For best results, use at least twice a week or as directed by a doctor
  • Use daily for maximum dandruff control
  • 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
  • Use daily for maximum dandruff control
  • Apply to wet scalp and hair. Leave for 1-3 minutes. Rinse well.

SOOTHING SERUM

  • Apply after usage of Medicating Cleanser and Moisturizing Conditioner to scalp.
  • Apply to affected areas one to four times daily or as directed by a doctor.

INACTIVE INGREDIENT SECTION

MEDICATING CLEANSER

Inactive ingredients water, sodium laureth sulfate, PEG-3 distearate, sodium laureth-8 sulfate, sodium chloride, cocamidopropyl betaine, acrylates/steareth-20 methacrylate copolymer, magnesium laureth-8 sulfate, magnesium laureth sulfate, sodium oleth sulfate, fragrance, sodium benzoate, citric acid, DMDM hydantoin, mentha arvensis leaf oil, mentha piperita (peppermint) oil, magnesium oleth sulfate, sodium hydroxide, polyquaternium-10, propylene glycol, benzoic acid, linalool, hexyl cinnamal, camellia sinensis leaf extract, sodium polynaphthalenesulfonate, benzyl alcohol, limonene, geraniol, cellulose gum, yeast extract, niacinamide, tocopheryl acetate, panthenol, biotin, lecithin, ethoxydiglycol, maltodextrin, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, urtica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.

MOISTURIZING CONDITIONER

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.

SOOTHING SERUM

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

MADE IN U.S.A. of U.S. and/or imported ingredients

Dist. Wella Operations US LLC,

Calabasas, CA 91302

www.nioxin.com

1-800-935-5273

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIOXIN®

SCALP RECOVERY

ANTI-DANDRUFF SYSTEM FOR ITCHY, FLAKY SCALP

COMBATS DANDRUFF FROM THE 1ST USE

STEP 1STEP 2STEP 3

PYRITHIONE ZINC

MEDICATING CLEANSER

PYRITHIONE ZINC

MOISTURIZING CONDITIONER

PYRITHIONE ZINC

SOOTHING SERUM

200 mL (6.76 FL OZ )200 mL ( 6.76 FL OZ) 100 mL ( 3.38 FL OZ)

82157-006 FOCA KIT PDP82157-006 FOCA KIT PDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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 · 76 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-00682157-006-99
82157-00382157-003-20
82157-00482157-004-20
82157-00582157-005-10

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 153 matching rows.

Name, UNII, Kind table
NameUNIIKind
LECITHIN, SOYBEAN1DI56QDM62IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
MAGNESIUM LAURETH SULFATEUKW9G007TZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
INOSITOL4L6452S749IACT
LACTIC ACID33X04XA5ATIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM BENZOATEOJ245FE5EUIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
BENZYL ALCOHOLLKG8494WBHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LIMONENE, (+/-)-9MC3I34447IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CHLORIDE451W47IQ8XIACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURETH-8 SULFATEYP8U3694P0IACT
SAGE065C5D077JIACT
CALCIUM PANTOTHENATE568ET80C3DIACT
MALTODEXTRIN7CVR7L4A2DIACT
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
CARAMELT9D99G2B1RIACT
NIACINAMIDE25X51I8RD4IACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
SODIUM OLEYL SULFATE46F21X4586IACT
MAGNESIUM OLETH SULFATELCQ4WP3DTLIACT
DMDM HYDANTOINBYR0546TOWIACT
PEPPERMINT OILAV092KU4JHIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GERANIOLL837108USYIACT
BIOTIN6SO6U10H04IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
BETULA PUBESCENS LEAF84SOH0O3OOIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BENZOIC ACID8SKN0B0MIMIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TARTARIC ACIDW4888I119HIACT

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
4474140d-11d0-ec27-e063-6294a90a77fde55a3a25-0fe9-f3ce-e053-2995a90a5cbb2025-11-25WarningsExact identifier
spl id: 4474140d-11d0-ec27-e063-6294a90a77fd
spl set id: e55a3a25-0fe9-f3ce-e053-2995a90a5cbb

Reported adverse events (FAERS/openFDA)#

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