FDA.reportPublic FDA data

DANDRUFF

Manufacturer
Xtreme Tools International, Inc
Effective date
2024-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:43:55

Label at a glance#

ProductDANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Dosage and administration

shake well For best results use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 2%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

Helps prevent itching and flaking associated with dandruff.

Warning

WARNINGS SECTION

For external use only.

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • For best results use at least twice a week or as directed by a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide MEA, Glycol Distearate, Polysorbate 20,PPG-10 Cetyl Ether, PEG-8, Polyquaternium-10, Acrylates, Vinyl Neodecanoate, Crosspolymer, Hydrolyzed Wheat Protein, Ricinus Communis (Castor) Seed Oil, Hydrolyzed Keratin, Chitosan Succinamide, Argania Spinosa (Argan) Kemel Oil, Olea Europaea (Olive) Oil, Sodium Benzoate, Pottassium Sorbate, Fragrance, Citric Acid, CI 42090

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-305-622-7474, Monday through Friday 9:00 AM to 5:00 PM

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 mL in Bottle; NDC 74553-003-01

SHAMPOOSHAMPOO

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74553-00374553-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARGAN OIL4V59G5UW9XIACT
OLIVE OIL6UYK2W1W1EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCOL DISTEARATE13W7MDN21WIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
COCO MONOETHANOLAMIDEC80684146DIACT
PPG-10 CETYL ETHERQ056X4917JIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN (1000 MW)8V0I3U3HMOIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
POLYQUATERNIUM-10 (125 MPA.S AT 2%)L45WU8S981IACT
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)2N8MDB79NAIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
VINYL NEODECANOATE9NDY01YYPTIACT
CASTOR OILD5340Y2I9GIACT
CHITOSAN SUCCINAMIDE (1300 MPA.S)41164V2SNSIACT

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
0b1a63a7-c8f9-4de5-a8ae-c87eb66ee0d4b0fab568-ffb8-2551-e053-2a95a90af23a2025-03-12WarningsExact identifier
spl set id: b0fab568-ffb8-2551-e053-2a95a90af23a

Reported adverse events (FAERS/openFDA)#

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