FDA.reportPublic FDA data

Axe

Manufacturer
Conopco, Inc. d/b/a Unilever
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:19

Label at a glance#

ProductAxe Signature Daily Dandruff Defense Anti-Dandruff
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

helps control scalp itching and flaking associated with dandruff.

Dosage and administration

Squeeze. Lather for several minutes. Rinse. Use at least twice a week or as directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

With Pyrithione Zinc (1.0% WW)

Purpose

OTC - PURPOSE SECTION

anti-dandruff

Uses

INDICATIONS & USAGE SECTION

  • helps control scalp itching and flaking associated with dandruff.

Warnings

WARNINGS SECTION

For External Use Only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Squeeze. Lather for several minutes. Rinse.
  • Use at least twice a week or as directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Fragrance (Parfum), Carbomer, Dimethiconol, DMDM Hydantoin, Citric Acid, PPG-9, Guar Hydroxypropyltrimonium Chloride, TEA-Dodecylbenzenesulfonate, Butylene Glycol, Iodopropynyl Butylcarbamate, Methylchloroisothiazolinone, Methylisothiazolinone

Questions?

OTC - QUESTIONS SECTION

1-800-450-7580

SPL UNCLASSIFIED SECTION

Consult a doctor prior to use in children under 2 years of age.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AXEAXE

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
64942-1483-12025-01-30C16284748780-19d75b9d0-35d4-f424-e053-dadaa90a57ceAxe Signature Daily Dandruff Defense Anti-Dandruff Shampoo
64942-1483-12021-03-10C16284748780-19d75b9d0-35d4-f424-e053-dadaa90a57ceAxe Signature Daily Dandruff Defense Anti-Dandruff Shampoo
64942-1483-12020-01-31C16284748780-19d75b9d0-35d4-f424-e053-dadaa90a57ceAxe Signature Daily Dandruff Defense Anti-Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64942-1483-1AxeSignature Daily Dandruff Defense Anti-Dandruff355 mL in 1 CONTAINERSHAMPOO3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64942-1483AXE SIGNATURE DAILY DANDRUFF DEFENSE ANTI-DANDRUFF (PYRITHIONE ZINC) SHAMPOO [CONOPCO, INC. D/B/A UNILEVER]3Legacy NDC, 1 package rows20221208_e8c90eb9-ac83-4b9f-859f-61af2b2a6e99.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64942-148364942-1483-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
DIMETHICONOL (40 CST)343C7U75XWIACT
DMDM HYDANTOINBYR0546TOWIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PPG-9I29VQH0G0BIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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
ef3cb591-4b71-3684-e053-2995a90a7791e8c90eb9-ac83-4b9f-859f-61af2b2a6e992022-12-07WarningsExact identifier
spl id: ef3cb591-4b71-3684-e053-2995a90a7791
spl set id: e8c90eb9-ac83-4b9f-859f-61af2b2a6e99

Reported adverse events (FAERS/openFDA)#

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