FDA.reportPublic FDA data

Zinc Therapy

Manufacturer
D3 Development, Inc.
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:23

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 are printed on back panel.

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

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 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 are printed on back panel.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, Avena Sativa (oat) kernel flour, olive oil, vitamin E, table salt, pentasodium pentetate

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of cartondermaharmony

Zinc Therapy SOAP

2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff

NET WT 4.0 OZ (113 G)

Zinc Therapy Bar FinalZinc Therapy Bar Final

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN4
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD4
283707zinc pyrithione 2 % Medicated Bar 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
71819-001-01Zinc Therapy28 g in 1 CELLO PACKSOAP284
71819-001-04Zinc Therapy113 g in 1 CELLO PACKSOAP1134
71819-001-05Zinc Therapy113 g in 1 CARTONSOAP1134
71819-001-44Zinc Therapy226 g in 1 CELLO PACKSOAP2264

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
71819-00171819-001-01, 71819-001-04, 71819-001-44, 71819-001-05

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
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SODIUM COCOATER1TQH25F4IIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
OLIVE OIL6UYK2W1W1EIACT
SODIUM PALMATES0A6004K3ZIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22020-03-24full-release2026-05-31 23:04:07

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.6b2de5ba-ad4b-5d43-e053-2991aa0ac3b22025-12-02WarningsExact identifier
ndc (package): 71819-001-05
ndc (package): 71819-001-01
ndc (package): 71819-001-04
ndc (package): 71819-001-44
ndc (product): 71819-001
ndc11 (package): 71819000144
ndc11 (package): 71819000104
ndc11 (package): 71819000101
ndc11 (package): 71819000105
spl id: 44fdf832-7277-4c93-e063-6294a90a61e1
spl set id: 6b2de5ba-ad4b-5d43-e053-2991aa0ac3b2

Reported adverse events (FAERS/openFDA)#

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