FDA.reportPublic FDA data

Assured

Manufacturer
Greenbrier International Inc.
Effective date
2021-08-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:01

Label at a glance#

ProductAssured
Active ingredientPYRITHIONE ZINC
Label structure13 sections

Storage and handling

Other information store at 20°C (69° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Pyrithione 1%

OTC - PURPOSE SECTION

Purpose

Anti-dandruff

INDICATIONS & USAGE SECTION

Use

  • helps prevent recurrence of flaking and itching associated with dandruff.

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

STORAGE AND HANDLING SECTION

Other information

  • store at 20°C (69° to 77°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauroamphoacetate, Glycol Distearate, Sodium Chloride, Fragrance, Citric Acid, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Yellow 5.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

Dandruff Shampoo

Dry Scalp Care

MOISTURIZING

RELIEVES

DRYNESS • ITCHING • FLAKING

13.5 FL OZ (400 mL)

Assured Dandruff ShampooAssured Dandruff Shampoo

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3
209884zinc pyrithione 1 % Medicated ConditionerSY3
209884zinc pyrithione 1 % Medicated ShampooSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-0700-12023-01-30C16284748780-1c7ccaba7-24d8-fd44-e053-dadaa90aa01bAssured Dandruff Shampoo
33992-0700-12021-08-23C16284748780-1c7ccaba7-24d8-fd44-e053-dadaa90aa01bAssured Dandruff Shampoo
33992-0700-12021-07-23C16284748780-1c7ccaba7-24d8-fd44-e053-dadaa90aa01bAssured Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-0700-1Assured400 mL in 1 BOTTLE, PLASTICSHAMPOO4003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-0700ASSURED (PYRITHIONE ZINC) SHAMPOO [GREENBRIER INTERNATIONAL INC.]3Legacy NDC, 1 package rows20210824_4688a1ed-9cd4-37a1-e054-00144ff8d46c.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
33992-070033992-0700-1

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
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DISODIUM ETHYLENEDIAMINEDIACETATEEQL53S5L0FIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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
ca3f225b-72e0-d0d8-e053-2995a90a50c04688a1ed-9cd4-37a1-e054-00144ff8d46c2021-08-23WarningsExact identifier
spl id: ca3f225b-72e0-d0d8-e053-2995a90a50c0
spl set id: 4688a1ed-9cd4-37a1-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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