FDA.reportPublic FDA data

URBAN WASH DANDRUFF - Primal Elements

Manufacturer
Primal Elements
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-15 03:01:35

Label at a glance#

ProductURBAN WASH DANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Dosage and administration

• shake well • for maximum dandruff control, use every time you shampoo • wet hair, massage onto scalp, rinse, repeat if desired • for best results, use at least twice a week or as directed by a doctor

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.3%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Use

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

When using this product do not get into 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 as directed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well • for maximum dandruff control, use every time you shampoo • wet hair, massage onto scalp, rinse, repeat if desired • for best results, use at least twice a week or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Styrene/Acrylates Copolymer, Guar Hydroxypropyltrimonium Chloride, Sodium Citrate, Fragrance, Sodium Chloride, Dimethicone, Methylisothiazolinone, Iodopropynyl Butylcarbamate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130744234702810GTIN-13: 0744234702810
EAN-13: 0744234702810
GTIN-12: 744234702810
UPC-A: 744234702810
GTIN storage (14 digits): 00744234702810		shampoo.jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80801-10180801-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM CHLORIDE451W47IQ8XIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
DIMETHICONE92RU3N3Y1OIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12023-05-01legacy-cache2026-08-01 21:31:18

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
fb274920-ea6b-386b-e053-6394a90a22e4fb274920-ea6a-386b-e053-6394a90a22e42023-05-01WarningsExact identifier
spl set id: fb274920-ea6a-386b-e053-6394a90a22e4

Reported adverse events (FAERS/openFDA)#

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