FDA.reportPublic FDA data

Dermaharmony Zinc Therapy

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 00:47:52

Label at a glance#

ProductDermaharmony Zinc Therapy
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Storage and handling

Other information Store at room temperature Lot number and expiration date on bottom

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Pyrithione zinc 2%

OTC - PURPOSE SECTION

Purposes

Dandruff, Seborrheic dermatitis

INDICATIONS & USAGE SECTION

Uses

Controls, reduces, and helps stop 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 haveseborrheic dermatitis that covers a large portion 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

  • Shake before each use
  • Use on affected areas in place of your regular soap
  • For best results use at least twice a week or as directed by a doctor
  • Work up a lather using warm water and massage into affected areas
  • Rinse well

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature
  • Lot number and expiration date on bottom

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Lauryl Glucoside, Cocamidopropyl Hydroxysultaine, Sodium Lauroamphoacetate, Distearyl Phthalic Acid Amide, Sodium Chloride, Lauramine Oxide, Melaleuca Alternifolia (Tea Tree) Oil, Soyethyl Morpholinium Ethosulfate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

OTC - QUESTIONS SECTION

Questions?

1-800-827-3730

SPL UNCLASSIFIED SECTION

Distributed by: D3 Development, Inc., Portland, ME 04101

Made in USA from U.S. and imported ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

Zinc Therapy CLEANSER

2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff

HELPS STOP: FLAKING, REDNESS, IRRITATION, SCALING

4 FL OZ (118 ml)

71819-016 Final71819-016 Final

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048123zinc pyrithione 2 % Medicated Liquid SoapPSN2
1048123zinc pyrithione 20 MG/ML Medicated Liquid SoapSCD2
1048123zinc pyrithione 2 % Medicated Liquid SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-016-04Dermaharmony Zinc Therapy118 mL in 1 BOTTLE, PLASTICLIQUID1182
71819-016-10Dermaharmony Zinc Therapy296 mL in 1 BOTTLE, PLASTICLIQUID2962
71819-016-12Dermaharmony Zinc Therapy355 mL in 1 BOTTLE, PLASTICLIQUID3552
71819-016-64Dermaharmony Zinc Therapy1893 mL in 1 BOTTLE, PLASTICLIQUID18932
71819-016-99Dermaharmony Zinc Therapy3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-016DERMAHARMONY ZINC THERAPY (PYRITHIONE ZINC) LIQUID [D3 DEVELOPMENT, INC.]2Current NDC, Legacy NDC, 5 package rows20241222_cb442483-b735-01a0-e053-2995a90aaff5.zip

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
71819-01671819-016-04, 71819-016-12, 71819-016-64, 71819-016-99, 71819-016-10

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
SODIUM CHLORIDE451W47IQ8XIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
SOYETHYL MORPHOLINIUM ETHOSULFATEJ8C5W5HH18IACT
DISTEARYL PHTHALAMIC ACID5552GSZ9LIIACT
TEA TREE OILVIF565UC2GIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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 Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.cb442483-b735-01a0-e053-2995a90aaff52024-12-20WarningsExact identifier
ndc (package): 71819-016-04
ndc (package): 71819-016-10
ndc (package): 71819-016-64
ndc (package): 71819-016-99
ndc (package): 71819-016-12
ndc (product): 71819-016
ndc11 (package): 71819001604
ndc11 (package): 71819001610
ndc11 (package): 71819001664
ndc11 (package): 71819001612
ndc11 (package): 71819001699
spl id: 29bad11f-2f6c-9b3d-e063-6394a90a4f86
spl set id: cb442483-b735-01a0-e053-2995a90aaff5

Reported adverse events (FAERS/openFDA)#

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