FDA.reportPublic FDA data

Zinc Therapy

Manufacturer
D3 Development, Inc. | Vanguard Soap, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:30

Label at a glance#

ProductZinc Therapy
Active ingredientPYRITHIONE ZINC
Label structure15 sections

Storage and handling

Other information Store at room temperature Lot number and expiration date can be found on the bottom of this container

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 can be found on the bottom of this container

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, potassium cocoate, potassium oleate, olive oil, vegetable glycerin, coco glucoside, salt, oatmeal, citric acid

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermaharmony

Zinc Therapy SOAP

2% Pyrithione Zinc for Seborrheic Dermatitis & Anti-Dandruff

MEDICATED NATURAL CASTILE SOAP

4 FL OZ (118 ml)

DH ZNP 2-2-18DH ZNP 2-2-18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1048123zinc pyrithione 2 % Medicated Liquid SoapPSN4
1048123zinc pyrithione 20 MG/ML Medicated Liquid SoapSCD4
1048123zinc pyrithione 2 % Medicated Liquid SoapSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71819-007-04Zinc Therapy118 mL in 1 BOTTLE, PLASTICLIQUID1184
71819-007-10Zinc Therapy296 mL in 1 BOTTLE, PLASTICLIQUID2964
71819-007-12Zinc Therapy355 mL in 1 BOTTLE, PLASTICLIQUID3554
71819-007-64Zinc Therapy1893 mL in 1 BOTTLE, PLASTICLIQUID18934
71819-007-99Zinc Therapy3785 mL in 1 BOTTLE, PLASTICLIQUID37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71819-007ZINC THERAPY (PYRITHIONE ZINC) LIQUID [D3 DEVELOPMENT, INC.]4Current NDC, Legacy NDC, 5 package rows20241222_637851c6-ff4a-8bbc-e053-2991aa0a963c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71819-00771819-007-04, 71819-007-12, 71819-007-64, 71819-007-99, 71819-007-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
POTASSIUM COCOATEF8U72V8ZXPIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YIACT
POTASSIUM OLEATE74WHF607EUIACT
OLIVE OIL6UYK2W1W1EIACT
COCO GLUCOSIDEICS790225BIACT
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
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.637851c6-ff4a-8bbc-e053-2991aa0a963c2024-12-20WarningsExact identifier
ndc (package): 71819-007-10
ndc (package): 71819-007-04
ndc (package): 71819-007-99
ndc (package): 71819-007-64
ndc (package): 71819-007-12
ndc (product): 71819-007
ndc11 (package): 71819000764
ndc11 (package): 71819000799
ndc11 (package): 71819000704
ndc11 (package): 71819000712
ndc11 (package): 71819000710
spl id: 29baa37a-11fd-d45b-e063-6294a90a12c4
spl set id: 637851c6-ff4a-8bbc-e053-2991aa0a963c

Reported adverse events (FAERS/openFDA)#

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