FDA.reportPublic FDA data

ANTIDANDRUFF

Manufacturer
BBCOS S.R.L.
Effective date
2016-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:09

Label at a glance#

ProductANTIDANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Indications and uses

Fights and helps prevents recurrence of flacking and itching associated with dandruff

Dosage and administration

For best results use at least twice a week or as directed by a dcoctor. Apply shampoo, massaging it thoroughly into the scalp. Rinse and repeat. Professional product.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Uses:

OTC - PURPOSE SECTION

Fights and helps prevents recurrence of flacking and itching associated with dandruff

Warnings:

WARNINGS SECTION

For external use only.

When using this product:

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop using this product and consult a doctor:

OTC - STOP USE SECTION

if conditions worsen or does not improve after regular use of this product 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 Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

For best results use at least twice a week or as directed by a dcoctor.

INDICATIONS & USAGE SECTION

Apply shampoo, massaging it thoroughly into the scalp. Rinse and repeat.

Professional product.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

AQUA (WATER), SODIUM LAURETH SULFATE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, GLYCERIN, LAURAMIDOPROPYL BETAINE, PROPYLENE GLYCOL, SODIUM PCA, PEG-7 GLYCERYL COCOATE, PEG-200 HYDROGENATED GLYCERYL PALMATE, PARFUM (FRAGRANCE), BENZYL ALCHOL, POTASSIUM SORBATE, SODIUM BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, TETRASODIUM EDTA, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, URTICA DIOICA (NETTLE) LEAF EXTRACT, MENTHA PIPERITA (MINT) EXTRACT, PEG/PPG-14/4 DIMETHICONE, PIROCTONE OLAMINE, CITRIC ACID, PANTHENOL, MENTHOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

artworkartworkGREEN

CARE

ESSENCE

ANTI-DANDRUFF

SHAMPOO

SAGE NETTLE MINT

PYRITHIONE ZINC

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70549-123-112020-01-31C16284748780-19d75b9d0-4192-f424-e053-dadaa90a57ceGREEN CARE ESSENCE ANTI-DANDRUFF SHAMPOO These highlights do not include all the information needed to use see full prescribing information for Initial U.S. Approval
70549-123-222020-01-31C16284748780-19d75b9d0-4192-f424-e053-dadaa90a57ceGREEN CARE ESSENCE ANTI-DANDRUFF SHAMPOO These highlights do not include all the information needed to use see full prescribing information for Initial U.S. Approval

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70549-123-11ANTIDANDRUFF1000 mg in 1 BOTTLE, PLASTICSHAMPOO10001
70549-123-22ANTIDANDRUFF250 mg in 1 BOTTLE, PLASTICSHAMPOO2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70549-123ANTIDANDRUFF (PYRITHIONE ZINC) SHAMPOO [BBCOS S.R.L.]1Legacy NDC, 2 package rows20160601_332e40fb-70a3-2e4f-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70549-12370549-123-11, 70549-123-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM CHLORIDE451W47IQ8XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
PEG-7 GLYCERYL COCOATEVNX7251543IACT
PEG-200 HYDROGENATED GLYCERYL PALMATEW161T051Y1IACT
EDETATE SODIUMMP1J8420LUIACT
BENZYL ALCOHOLLKG8494WBHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
PEG/PPG-14/4 DIMETHICONE646XNV22YXIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
PANTHENOLWV9CM0O67ZIACT
MENTHOLL7T10EIP3AIACT
SAGE065C5D077JIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
MENTHA PIPERITA79M2M2UDA9IACT

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
332e40fb-70a4-2e4f-e054-00144ff8d46c332e40fb-70a3-2e4f-e054-00144ff8d46c2016-05-19WarningsExact identifier
spl id: 332e40fb-70a4-2e4f-e054-00144ff8d46c
spl set id: 332e40fb-70a3-2e4f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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