FDA.reportPublic FDA data

Zincon Medicated Dandruff

Manufacturer
Neoteric Cosmetics, Inc.
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:44:40

Label at a glance#

ProductZincon Medicated Dandruff
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Indications and uses

Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis.

Dosage and administration

Shake well Wet hair, apply shampoo and work into lather Rinse thoroughly For best results, use at least twice a week or as directed by a doctor Do not use on children under 2 years of age, except as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

(To the right)

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

  • Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff and seborrheic dermatitis.

Warnings:

WARNINGS SECTION

  • For external use only.

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

have a condition that covers a large area of the body.

When using this product 

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Condition does not improve after regular use of this product as directed.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Shake well
  • Wet hair, apply shampoo and work into lather
  • Rinse thoroughly
  • For best results, use at least twice a week or as directed by a doctor
  • Do not use on children under 2 years of age, except as directed by a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, cocamide MEA, deionized water, FD & C Blue No. 1, Fragrance, glycol distearate, magnesium aluminum silicate, methylchloroisothiazolinone, methylisothiazolinone, propylene glycol, sodium chloride, sodium laureth sulfate, sodium lauryl sulfate.

Questions? 1-800-220-0151

Manufactured for Neoteric Cosmetics, Inc.

Denver, CO 80239

WWW. Neotericcosmetics.com MADE IN USA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pyrithione Zinc
ZINCON
MEDICATED
DANDRUFF SHAMPOO

  • Controls dandruff itching & flaking
  • Leaves hair clean & easy to manage
  • Pleasant fragrance

4 fl.oz. (118ml)

PRINCIPAL DISPLAY PANEL Pyrithione Zinc ZINCON MEDICATED DANDRUFF SHAMPOO • Controls dandruff itching & flaking • Leaves hair clean & easy to manage • Pleasant fragrance 4 fl.oz...PRINCIPAL DISPLAY PANEL Pyrithione Zinc ZINCON MEDICATED DANDRUFF SHAMPOO • Controls dandruff itching & flaking • Leaves hair clean & easy to manage • Pleasant fragrance 4 fl.oz...

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pyrithione Zinc
ZINCON
MEDICATED
DANDRUFF SHAMPOO

  • Controls dandruff itching & flaking
  • Leaves hair clean & easy to manage
  • Pleasant fragrance

8 fl.oz. (236ml)

PRINCIPAL DISPLAY PANEL Pyrithione Zinc ZINCON MEDICATED DANDRUFF SHAMPOO • Controls dandruff itching & flaking • Leaves hair clean & easy to manage • Pleasant fragrance 8 fl.oz...PRINCIPAL DISPLAY PANEL Pyrithione Zinc ZINCON MEDICATED DANDRUFF SHAMPOO • Controls dandruff itching & flaking • Leaves hair clean & easy to manage • Pleasant fragrance 8 fl.oz...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN5
1246250Zincon Dandruff 1 % Medicated ShampooPSN5
1246250zinc pyrithione 10 MG/ML Medicated Shampoo [Zincon]SBD5
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD5
209884zinc pyrithione 1 % Medicated ConditionerSY5
209884zinc pyrithione 1 % Medicated ShampooSY5
1246250Zincon 10 MG/ML Medicated ShampooSY5
1246250Zincon Dandruff 1 % Medicated ShampooSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62673-016-942025-07-29C16284748780-1d6a99b39-f5b7-a426-e053-dadaa90af4c2Zincon Medicated Dandruff Shampoo 4oz
62673-016-982025-07-29C16284748780-1d6a99b39-f5b7-a426-e053-dadaa90af4c2Zincon Medicated Dandruff Shampoo 4oz
62673-016-942024-12-18C16284748780-1d6a99b39-f5b7-a426-e053-dadaa90af4c2Zincon Medicated Dandruff Shampoo 4oz
62673-016-982024-12-18C16284748780-1d6a99b39-f5b7-a426-e053-dadaa90af4c2Zincon Medicated Dandruff Shampoo 4oz
62673-016-942022-01-28C16284748780-1d6a99b39-f5b7-a426-e053-dadaa90af4c2Zincon Medicated Dandruff Shampoo 4oz
62673-016-982022-01-28C16284748780-1d6a99b39-f5b7-a426-e053-dadaa90af4c2Zincon Medicated Dandruff Shampoo 4oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62673-016-94Zincon Medicated Dandruff118 mL in 1 BOTTLESHAMPOO1185
62673-016-98Zincon Medicated Dandruff236 mL in 1 BOTTLESHAMPOO2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62673-016ZINCON MEDICATED DANDRUFF (PYRITHIONE ZINC) SHAMPOO [NEOTERIC COSMETICS, INC.]5Legacy NDC, 2 package rows20241220_603b9e94-a7b8-b6e5-e053-2a91aa0a05fd.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62673-01662673-016-94, 62673-016-98

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO MONOETHANOLAMIDEC80684146DIACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCOL DISTEARATE13W7MDN21WIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML · Source PDF

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
23e91dc8-9a21-5e59-e063-6294a90a1e52603b9e94-a7b8-b6e5-e053-2a91aa0a05fd2024-10-07WarningsExact identifier
spl id: 23e91dc8-9a21-5e59-e063-6294a90a1e52
spl set id: 603b9e94-a7b8-b6e5-e053-2a91aa0a05fd

Reported adverse events (FAERS/openFDA)#

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