FDA.reportPublic FDA data

Nioxin Scalp Recovery

Manufacturer
The Wella Corporation | Coty US LLC | Thibiant International, Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:45:14

Label at a glance#

ProductNioxin Scalp Recovery Medicating Cleanser
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

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 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

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, FRAGRANCE, DMDM HYDANTOIN, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, MENTHA ARVENSIS LEAF OIL, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, YEAST EXTRACT, LECITHIN, SACCHAROMYCES/MAGNESIUM FERMENT, BIOTIN/FOLIC ACID/CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST POLYPEPTIDES, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT.

Questions?

OTC - QUESTIONS SECTION

1-800-935-5273

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NIOXIN ®
SCALP RECOVERY ®

For a dry, itchy scalp

PYRITHIONE ZINC
DANDRUFF AND
SEBORRHEIC
DERMATITIS
SHAMPOO

MEDICATING
CLEANSER

100% FLAKE FREE
ELIMINATION OF
VISIBLE FLAKES WITH
REGULAR USE

99405984

200 mL (6.76 FL OZ)

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69282-005-102022-12-22C16284748780-1e4f33bdf-a437-d8a0-e053-dadaa90a6e4eNioxin ® Scalp Recovery ® Medicating Cleanser
69282-005-202022-12-22C16284748780-1e4f33bdf-a437-d8a0-e053-dadaa90a6e4eNioxin ® Scalp Recovery ® Medicating Cleanser
69282-005-502022-12-22C16284748780-1e4f33bdf-a437-d8a0-e053-dadaa90a6e4eNioxin ® Scalp Recovery ® Medicating Cleanser
69282-005-102022-07-29C16284748780-1e4f33bdf-a437-d8a0-e053-dadaa90a6e4eNioxin ® Scalp Recovery ® Medicating Cleanser
69282-005-202022-07-29C16284748780-1e4f33bdf-a437-d8a0-e053-dadaa90a6e4eNioxin ® Scalp Recovery ® Medicating Cleanser
69282-005-502022-07-29C16284748780-1e4f33bdf-a437-d8a0-e053-dadaa90a6e4eNioxin ® Scalp Recovery ® Medicating Cleanser

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69282-00569282-005-50, 69282-005-20, 69282-005-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCO MONOETHANOLAMIDEC80684146DIACT
ZINC CARBONATEEQR32Y7H0MIACT
GLYCOL DISTEARATE13W7MDN21WIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
DMDM HYDANTOINBYR0546TOWIACT
PEPPERMINT OILAV092KU4JHIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
BENZYL ALCOHOLLKG8494WBHIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

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
297db27b-1e78-c0e2-e063-6294a90a3aec38d2c149-98a6-41f1-a596-10bcf48f8ca42024-12-17WarningsExact identifier
spl id: 297db27b-1e78-c0e2-e063-6294a90a3aec
spl set id: 38d2c149-98a6-41f1-a596-10bcf48f8ca4