FDA.reportPublic FDA data

Dandruff

Manufacturer
Vi-Jon, LLC
Effective date
2023-02-03
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:38:17

Label at a glance#

ProductDandruff
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Dosage and administration

shake well for maximum dandruff control, use every time you shampoo wet hair, massage 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#

Optional Claims

SPL UNCLASSIFIED SECTION

Multiple benefit formula to help:

  • Fight dry scalp
  • Calm itch
  • Relieve iritation
  • Soothe and reduce redness
  • Reduce oilness
  • Prevent flakes
  • Leave hair healthy looking

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, massage 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

Dislcaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Classic Clean pyrithione zinc Dandruff Shampoo

Adverse Reaction

ADVERSE REACTIONS SECTION

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA

with US and foreign parts

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mountain

falls

Compare to Head & Shoulders

helps prevent flakes

leaves hair clean and manageable

helps relieve scalp dryness, itch and irritation

pH balanced formula

dandruff shampoo

with pyrithione zinc

everyday clean

14.2 FL OZ (420 mL)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0869-01530869-0153-15, 0869-0153-86, 0869-0153-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CARBONATEEQR32Y7H0MIACT
SODIUM XYLENESULFONATEG4LZF950URIACT
AMODIMETHICONE (800 CST)363Z2T48P7IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
MAGNESIUM CARBONATE HYDROXIDEYQO029V1L4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

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
10436c76-1030-a8fe-e063-6394a90a86fc9fb3c6b7-bb52-4785-bb35-c1c8d158999e2024-01-31Warnings, Adverse reactionsExact identifier
spl set id: 9fb3c6b7-bb52-4785-bb35-c1c8d158999e

Reported adverse events (FAERS/openFDA)#

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