FDA.reportPublic FDA data

Nioxin Scalp Recovery Soothing Serum

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 17:40:48

Label at a glance#

ProductNioxin Scalp Recovery 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 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

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® SOOTHING SERUM

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

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®

PYRITHIONE ZINC

SOOTHING SERUM

STEP 3
SCALP RECOVERY

FOR ITCHY FLAKY SCALP

COMBATS DANDRUFF FROM THE 1ST USE

100 mL (3.38 FL OZ)

82157-005 PDP82157-005 PDP

82157-005 Back82157-005 Back

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130004600305411GTIN-13: 0004600305411
EAN-13: 0004600305411
GTIN-12: 004600305411
UPC-A: 004600305411
GTIN storage (14 digits): 00004600305411		82157-005 Back.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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 · 57 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82157-00582157-005-10

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 56 matching rows.

Name, UNII, Kind table
NameUNIIKind
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
URTICA DIOICA LEAFX6M0DRN46QIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
ROSEMARYIJ67X351P9IACT
EQUISETUM ARVENSE BRANCH1L0VKZ185EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
WATER059QF0KO0RIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
CETYL ALCOHOL936JST6JCNIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYETHYLENE OXIDE 100000V46Y6OJ5QBIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OLEYL ALCOHOL172F2WN8DVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYSORBATE 60CAL22UVI4MIACT
PEPPERMINT OILAV092KU4JHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM PHOSPHATESE337SVY37IACT
BETULA PUBESCENS LEAF84SOH0O3OOIACT
SODIUM BENZOATEOJ245FE5EUIACT
INOSITOL4L6452S749IACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
BIOTIN6SO6U10H04IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT
LIMONENE, (+/-)-9MC3I34447IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
44740f83-1397-ed00-e063-6294a90ac66ae4f85007-12d7-b22d-e053-2995a90aa1262025-11-25WarningsExact identifier
spl id: 44740f83-1397-ed00-e063-6294a90ac66a
spl set id: e4f85007-12d7-b22d-e053-2995a90aa126

Reported adverse events (FAERS/openFDA)#

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