FDA.reportPublic FDA data

TEA TREE OIL DANDRUFF SHAMPOO

Manufacturer
Universal Distribution Center LLC
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-27 00:01:59

Label at a glance#

ProductTEA TREE Oil DANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Indications and uses

helps remove flakes and relieve itching associated with dandruff while gently cleansing hair and scalp.

Dosage and administration

• Shake well before use. • Wet hair thoroughly, apply shampoo to scalp, and massage gently. • Rinse thoroughly and repeat if desired. • For best results, use at least twice weekly or as directed by a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.5%

PURPOSE

OTC - PURPOSE SECTION

Anti-dandruff

USES

INDICATIONS & USAGE SECTION

helps remove flakes and relieve itching associated with dandruff while gently cleansing hair and scalp.

WARNINGS

WARNINGS SECTION

For external use only.

WHEN USING THIS PRODUCT
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation occurs or condition worsens after regular use.

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 before use.
• Wet hair thoroughly, apply shampoo to scalp, and massage gently.
• Rinse thoroughly and repeat if desired.
• For best results, use at least twice weekly or as directed by a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water(Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Polyquaternium-7, Glycerin, Dimethicone, Guar Hydroxypropyltrimonium Chloride, Styrene/Acrylates Copolymer, Sodium Citrate, Methylisothiazolinone, Iodopropynyl Butylcarbamate, Fragrance, Sodium Chloride, Melaleuca Alternifolia (Tea Tree) Leaf Oil, FD&C Blue No. 1, FD&C Yellow No.5

SPL UNCLASSIFIED SECTION

LONG-LASTING FRESHNESS

Refreshes & Soothes Scalp

PYRITHIONE ZINC FORMULA

• Helps Control Dandruff

• Relieves Itching & Flaking

• For All Hair Types

U® Anti-Dandruff Shampoo – Tea Tree Oil helps control dandruff while gently cleansing hair and scalp. Formulated with tea tree oil, it helps soothe the scalp and reduce flaking, leaving hair feeling clean, refreshed, and manageable.

*This product is not manufactured, distributed, or endorsed by Procter & Gamble, the owner of the registered trademark Head & Shoulders®.

Manufactured for & Distributed by
Universal Distribution Center LLC
330 Applegarth Road,
Monroe Township,NJ 08831
www.universaldc.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TeaTreeOilShampooTeaTreeOilShampoo

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130676979561141GTIN-13: 0676979561141
EAN-13: 0676979561141
GTIN-12: 676979561141
UPC-A: 676979561141
GTIN storage (14 digits): 00676979561141		52000455-2.jpg

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-45552000-455-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCO MONOETHANOLAMIDEC80684146DIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEB16G315W7AIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOCARB603P14DHEBIACT
SODIUM CHLORIDE451W47IQ8XIACT
TEA TREE OILVIF565UC2GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
TEA TREE Oil DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC280391ce-ccd9-4b39-95a2-93e7fca84ccc2026-08-18WarningsExact identifier
ndc (package): 52000-455-12
ndc (product): 52000-455
ndc11 (package): 52000045512
spl id: 1ddf374a-2ea2-40aa-a4ec-9ff225b1c7b3
spl set id: 280391ce-ccd9-4b39-95a2-93e7fca84ccc

Reported adverse events (FAERS/openFDA)#

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