FDA.reportPublic FDA data

Dandruff

Manufacturer
Malin and Goetz Inc | Milbar Laboratories, Inc.
Effective date
2021-01-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:54:34

Label at a glance#

ProductDandruff
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient              Purpose

Pyrithizone Zinc 1.9%      Anti-Dandruff

OTC - PURPOSE SECTION

Uses Controls the symptoms of:

  • dandruff 
  • seborrheic dermatitis

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if

too much skin irritation or sensitivity develops and increases

WARNINGS SECTION

Warnings

For external use only

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

DOSAGE & ADMINISTRATION SECTION

Directions

  • for best results, use at least twice a week or as directed by a doctor
  • Wet hair thoroughly, pour into palm; rub hands together to form a rich lather and massage into scalp
  • Rinse thoroughly
  • repeat if desired

INACTIVE INGREDIENT SECTION

Water (aqua), Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Acrylates/C1-30 Alkyl Acrylate Crosspolymer, Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Sorbate, Sodium Hydroxide, Glycerin, Disodium EDTA, Eucalyptus Globulus Leaf Extract, Limonene, Panthenol, Betaine, Hydrolyzed Wheat Starch, Serine, Glutamic Acid, Glycine, Lysine, Alanine, Arginine, Threonine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(Malin+Goetz)

Dandruff Shampoo

8fl.oz. 236ml

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53634-127-012023-06-27C16284748780-1f386c64a-3583-0266-e053-dadaa90a7c1aDandruff Shampoo
53634-127-012023-01-30C16284748780-1f386c64a-3583-0266-e053-dadaa90a7c1aDandruff Shampoo

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53634-12753634-127-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
SODIUM BENZOATEOJ245FE5EUIACT
TEA TREE OILVIF565UC2GIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
EUCALYPTUS OIL2R04ONI662IACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
LIMONENE, (+)-GFD7C86Q1WIACT
PANTHENOLWV9CM0O67ZIACT
BETAINE3SCV180C9WIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
SORBITOL506T60A25RIACT
PROLINE9DLQ4CIU6VIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
SERINE452VLY9402IACT
GLUTAMIC ACID3KX376GY7LIACT
GLYCINETE7660XO1CIACT
LYSINEK3Z4F929H6IACT
ALANINEOF5P57N2ZXIACT
ARGININE94ZLA3W45FIACT
THREONINE2ZD004190SIACT
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
ff24fd27-6d7b-5fdc-e053-6294a90a48f81eeaee85-e231-4b49-b643-c1d1aabf86422023-06-27WarningsExact identifier
spl set id: 1eeaee85-e231-4b49-b643-c1d1aabf8642

Reported adverse events (FAERS/openFDA)#

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