FDA.reportPublic FDA data

modesa 2 in 1 dandruff

Manufacturer
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.
Effective date
2019-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:03

Label at a glance#

Productmodesa 2 in 1 dandruff
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                               Purpose

Pyrithione Zinc             1.00%                            Anti-dandruff

OTC - PURPOSE SECTION

Help prevent to treat flakes, itch, irritation, oilness or dryness caused by dandruff.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center （1-800-222-1222）right away.
Avoid contact with eyes, if contact occurs rinse eyes with plenty of water.

INDICATIONS & USAGE SECTION

wet hair, squeeze small amount to palm, lather, rinse well for best results use at least twice a week or as directed by a doctor.

WARNINGS SECTION

For external use only.

Stop use and ask a doctor if Condition worsens or does not improve after regular use as directed.

DOSAGE & ADMINISTRATION SECTION

small amount to palm, or as directed by a doctor.

INACTIVE INGREDIENT SECTION

water, sodium laureth sulfate, cocamide MEA, glycol distearate, acrylates copolymer, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, fragrance, guar hydroxypropyltrimonium chloride, zinc sulfate, dimethicone, cetyl alcohol, benzyl alcohol, sodium hydroxide, citric acid, sodium benzoate, FD&C blue no. 1, D&C red no. 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of shampoo
image of shampoo

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40104-436-012020-09-27C16284748780-1ab0e2407-2e9a-f274-e053-dbdaa90a64718be6a276-5797-41de-91f1-09b02b6887ea
40104-436-022020-09-27C16284748780-1ab0e2407-2e9a-f274-e053-dbdaa90a64718be6a276-5797-41de-91f1-09b02b6887ea
40104-436-012020-09-25C16284748780-1ab0e2407-2e9a-f274-e053-dbdaa90a64718be6a276-5797-41de-91f1-09b02b6887ea
40104-436-022020-09-25C16284748780-1ab0e2407-2e9a-f274-e053-dbdaa90a64718be6a276-5797-41de-91f1-09b02b6887ea
40104-436-012020-07-22C16284748780-1ab0e2407-2e9a-f274-e053-dbdaa90a64718be6a276-5797-41de-91f1-09b02b6887ea
40104-436-022020-07-22C16284748780-1ab0e2407-2e9a-f274-e053-dbdaa90a64718be6a276-5797-41de-91f1-09b02b6887ea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40104-436-01modesa 2 in 1 dandruff696.8 g in 1 BOTTLE, PLASTICSHAMPOO696.81
40104-436-02modesa 2 in 1 dandruff396.9 g in 1 PACKAGESHAMPOO396.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40104-436MODESA 2 IN 1 DANDRUFF (PYRITHIONE ZINC) SHAMPOO [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.]1Legacy NDC, 2 package rows20190402_8be6a276-5797-41de-91f1-09b02b6887ea.zip

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
40104-43640104-436-01, 40104-436-02

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
water059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCOL DISTEARATE13W7MDN21WIACT
SODIUM CHLORIDE451W47IQ8XIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
ZINC SULFATE89DS0H96TBIACT
DIMETHICONE92RU3N3Y1OIACT
CETYL ALCOHOL936JST6JCNIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID, 1-STEARYL ESTERE945AJ51FAIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
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
ce878db1-e006-4460-84e6-a797f3a842a58be6a276-5797-41de-91f1-09b02b6887ea2019-04-02WarningsExact identifier
spl id: ce878db1-e006-4460-84e6-a797f3a842a5
spl set id: 8be6a276-5797-41de-91f1-09b02b6887ea

Reported adverse events (FAERS/openFDA)#

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