FDA.reportPublic FDA data

Dermaharmony Tea Tree Bar

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:01

Label at a glance#

ProductDermaharmony Tea Tree Bar
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Storage and handling

Other information Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Pyrithione zinc 2%

OTC - PURPOSE SECTION

Purpose

Dandruff / seborrheic dermatitis shampoo

INDICATIONS & USAGE SECTION

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you havea condition that covers a large area of the body.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifcondition worsens or does not improve after regular use as directed.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Use on affected areas in place of your regular shampoo
  • For best results use at least twice a week or as directed by a doctor
  • Rub between hands to create a lather, or apply bar directly onto hair
  • Massage into the hair and scalp for 60-90 seconds, then rinse well

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre).

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in USA of U.S. and imported ingredients.

NDC Code: 71819-018-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

TEA TREE Shampoo Bar

with 2% Pyrithione Zinc

FOR DANDRUFF & SEBORRHEIC DERMATITIS

NET WT 4 OZ (113G)

Dandruff Shampoo 71819-018-04Dandruff Shampoo 71819-018-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244458zinc pyrithione 2 % Medicated ShampooPSN2
244458zinc pyrithione 20 MG/ML Medicated ShampooSCD2
244458zinc pyrithione 2 % Medicated ShampooSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-018-04Dermaharmony Tea Tree Bar113 g in 1 CARTONSHAMPOO1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-018DERMAHARMONY TEA TREE BAR (PYRITHIONE ZINC) SHAMPOO [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_e9d5eb14-1840-ae21-e053-2a95a90aa321.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-01871819-018-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YIACT
TEA TREE OILVIF565UC2GIACT
DEHYDROACETIC ACID2KAG279R6RIACT
ARGAN OIL4V59G5UW9XIACT
DISODIUM 2-SULFOLAURATE329M3829G2IACT
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT
SODIUM ISOSTEAROYL LACTYLATE8730J0D3EVIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
STEARIC ACID4ELV7Z65APIACT
COCONUT ACID40U37V505DIACT
SOYETHYL MORPHOLINIUM ETHOSULFATEJ8C5W5HH18IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM METHYL 2-SULFOLAURATEI39GGJ23HVIACT
SODIUM ISETHIONATE3R36J71C17IACT
SUCROSE COCOATE3H18P0UK73IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
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
Dermaharmony Tea Tree BarPYRITHIONE ZINCD3 Development, Inc.e9d5eb14-1840-ae21-e053-2a95a90aa3212024-12-20WarningsExact identifier
ndc (package): 71819-018-04
ndc (product): 71819-018
ndc11 (package): 71819001804
spl id: 29bad356-6711-ee98-e063-6394a90adc73
spl set id: e9d5eb14-1840-ae21-e053-2a95a90aa321

Reported adverse events (FAERS/openFDA)#

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