FDA.reportPublic FDA data

Nioxin Scalp Recovery

Manufacturer
The Wella Corporation | Coty US LLC | Thibiant International, Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:44:24

Label at a glance#

ProductNioxin Scalp Recovery Soothing Serum
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Dosage and administration

apply to affected areas one to four times daily or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, Anti-seborrheic dermatitis

Uses

INDICATIONS & USAGE SECTION

  • helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a condition that covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply to affected areas one to four times daily or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, stearamidopropyl dimethylamine, cetyl alcohol, hydroxyethylcellulose, quaternium-18, benzyl alcohol, phenoxyethanol, stearyl alcohol, PEG-2M, dimethicone, cetearyl alcohol, methylparaben, propylparaben, fragrance, glyceryl stearate, oleyl alcohol, citric acid, polysorbate 60, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, yeast extract, camellia sinensis leaf extract, lecithin, PPG-26-buteth-26, saccharomyces/magnesium ferment, dimethyl isosorbide, carnitine HCL, PEG/PPG-18/18 dimethicone, ethoxydiglycol, oryza sativa (rice) bran, PEG-40 hydrogenated castor oil, biotin/folic acid/cyanocobalamin/niacinamide/pantothenic acid/pyridoxine/riboflavin/thiamine/yeast polypeptides, saccharomyces/iron ferment, saccharomyces/copper ferment, saccharomyces/silicon ferment, saccharomyces/zinc ferment, acacia senegal gum, ubiquinone.

Questions?

OTC - QUESTIONS SECTION

1-800-935-5273

SPL UNCLASSIFIED SECTION

Dist. by
THE WELLA CORPORATION,
WOODLAND HILLS, CA 91367

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIOXIN ®
SCALP RECOVERY ®

For a dry, itchy scalp

PYRITHIONE ZINC
DANDRUFF AND
SEBORRHEIC
DERMATITIS
TREATMENT

SOOTHING
SERUM

100% FLAKE FREE
ELIMINATION OF
VISIBLE FLAKES WITH
REGULAR USE*

100 mL (3.38 FL OZ)

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69282-006-102022-12-22C16284748780-1e4f33bdf-a7fc-d8a0-e053-dadaa90a6e4eNioxin Scalp Recovery Soothing Serum
69282-006-502022-12-22C16284748780-1e4f33bdf-a7fc-d8a0-e053-dadaa90a6e4eNioxin Scalp Recovery Soothing Serum
69282-006-102022-07-29C16284748780-1e4f33bdf-a7fc-d8a0-e053-dadaa90a6e4eNioxin Scalp Recovery Soothing Serum
69282-006-502022-07-29C16284748780-1e4f33bdf-a7fc-d8a0-e053-dadaa90a6e4eNioxin Scalp Recovery Soothing Serum

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69282-00669282-006-50, 69282-006-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PPG-26-BUTETH-262II1K6TZ4PIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
LEVOCARNITINE HYDROCHLORIDEJ3Y5E6IKS3IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
RICE BRANR60QEP13ICIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
ACACIA5C5403N26OIACT
UBIDECARENONEEJ27X76M46IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
CETYL ALCOHOL936JST6JCNIACT
QUATERNIUM-18O7757NO1VLIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYETHYLENE OXIDE 100000V46Y6OJ5QBIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OLEYL ALCOHOL172F2WN8DVIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYSORBATE 60CAL22UVI4MIACT

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
29f2c6db-ffda-a721-e063-6294a90a327b7567d5bf-2825-48c4-8525-19ff34c7a64e2024-12-23WarningsExact identifier
spl id: 29f2c6db-ffda-a721-e063-6294a90a327b
spl set id: 7567d5bf-2825-48c4-8525-19ff34c7a64e

Reported adverse events (FAERS/openFDA)#

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