FDA.reportPublic FDA data

Fresh Mint Dandruff

Manufacturer
Vi Jon
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:45:41

Label at a glance#

ProductFresh Mint Dandruff
Active ingredientPYRITHIONE ZINC
Label structure7 sections

Dosage and administration

• shake well  • for maximum dandruff control, use every time you shampoo • wet hair, message onto scalp, rinse, repeat if desired • for best results use at least twice a week or as directed by a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

purpose

OTC - PURPOSE SECTION

Anti-dandruff

use

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

• do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens or does not improve after regular use 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  • for maximum dandruff control, use every time you shampoo • wet hair, message onto scalp, rinse, repeat if desired • for best results use at least twice a week or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dandruff Shampoo
14.2 FL OZ (420 mL)

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11344-309-152024-12-18C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309
11344-309-212024-12-18C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309
11344-309-352024-12-18C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309
11344-309-392024-12-18C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309
11344-309-152022-01-28C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309
11344-309-212022-01-28C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309
11344-309-352022-01-28C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309
11344-309-392022-01-28C16284748780-1d6a99b39-376d-a426-e053-dadaa90af4c2Dandruff Shampoo 309

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11344-30911344-309-15, 11344-309-21, 11344-309-35, 11344-309-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCOL DISTEARATE13W7MDN21WIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
AMODIMETHICONE (1300 CST)3V7U636DWNIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE0E53J927NAIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 3PN2ZH5LOQYIACT

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
298ff251-0583-2b94-e063-6394a90ac89b4a06ee5f-736c-40ce-88eb-86f63e0195662024-12-18WarningsExact identifier
spl set id: 4a06ee5f-736c-40ce-88eb-86f63e019566

Reported adverse events (FAERS/openFDA)#

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