FDA.reportPublic FDA data

Zinc Pyrithione

Manufacturer
Harry's Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:17

Label at a glance#

ProductZinc Pyrithione
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Indications and uses

for relief and to help prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

• for best results use at least twice a week or as directed by a doctor. • shake before use. • wet hair, massage onto scalp, rinse, repeat if desired.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

for relief and to help prevent recurrence of
flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with 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 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

• for best results use at least twice a week or as
directed by a doctor.
• shake before use.
• wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Lauric Acid, Disodium Cocoamphodiacetate, Decyl Glucoside, Polysorbate 20, Sodium Chloride, Citric Acid, Acrylates Copolymer, Glycerin, Phenoxyethanol, Polyquaternium-6, Coconut Acid, Mentha Piperita (Peppermint) Oil, PEG-120 Methyl Glucose Dioleate, Polyquaternium-67, Coco-Glucoside, Glyceryl Oleate, Eucalyptus Globulus Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Menthol, Butylene Glycol, Lavandula Hybrida Oil, Carica Papaya (Papaya) Fruit Extract, Chlorphenesin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Raphanus Sativus (Radish)
Root Extract, Potassium Hydroxide , Sodium Lauroyl Lactylate, Lavandula Angustifolia (Lavender) Oil, Sodium Caproyl Lactylate,
Propylene Glycol, Ferula Galbaniflua (Galbanum) Resin Oil, Sodium Polynaphthalenesulfonate, Sodium Acetate, Piper Nigrum (Pepper) Fruit Extract, Xanthan Gum, Isopropyl Alcohol, Benzoic Acid, Dehydroacetic Acid, Inga Alba Bark Extract, Tocopherol, Hydrogenated Palm Glycerides, Lecithin, Ascorbyl Palmitate, Linalool, Limonene.

OTC - QUESTIONS SECTION

Questions? 1-888-212-6855

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

414ml NDC: 70533-003-14

414 ml414 ml

59ml NDC: 70533-003-02

front NDC 70533-003-02front NDC 70533-003-02back NDC 70533-003-02back NDC 70533-003-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN6
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD6
209884zinc pyrithione 1 % Medicated ConditionerSY6
209884zinc pyrithione 1 % Medicated ShampooSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70533-003-022024-12-17C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-142024-12-17C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-022024-07-30C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-142024-07-30C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-022024-01-30C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-142024-01-30C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-022021-08-27C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-142021-08-27C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-022021-07-23C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff
70533-003-142021-07-23C16284748780-1c7ccaba7-23c1-fd44-e053-dadaa90aa01bAnti-dandruff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70533-003-02Zinc Pyrithione59 mL in 1 TUBESHAMPOO596
70533-003-14Zinc Pyrithione414 mL in 1 BOTTLESHAMPOO4146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70533-003ZINC PYRITHIONE SHAMPOO [HARRY'S INC.]6Legacy NDC, 2 package rows20241219_a4fecf11-dd44-a06e-e053-2995a90afacf.zip

Products#

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

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70533-00370533-003-14, 70533-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
DECYL GLUCOSIDEZ17H97EA6YIACT
POLYQUATERNIUM-6 (15000 MW)YFL33X52PXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LIMONENE, (+/-)-9MC3I34447IACT
FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW)90D834OZUIIACT
ALOEV5VD430YW9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PAPAYAKU94FIY6JBIACT
LAURIC ACID1160N9NU9UIACT
INGA ALBA BARK942K688993IACT
TOCOPHEROLR0ZB2556P8IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYQUATERNIUM-10 (400 CPS AT 2%)HB1401PQFSIACT
SODIUM CHLORIDE451W47IQ8XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
LAVANDIN OIL9RES347CKGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCO GLUCOSIDEICS790225BIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
RACEMENTHOLYS08XHA860IACT
CHLORPHENESINI670DAL4SZIACT
TEA TREE OILVIF565UC2GIACT
GALBANUM OIL211UF7M8N1IACT
DEHYDROACETIC ACID2KAG279R6RIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
GLYCERYL OLEATE4PC054V79PIACT
EUCALYPTUS OIL2R04ONI662IACT
LINALOOL, (+/-)-D81QY6I88EIACT
SODIUM ACETATE ANHYDROUSNVG71ZZ7P0IACT
WHITE PEPPERM29DW54Q9EIACT
RAPHANUS SATIVUS VAR. CAUDATUS ROOT1D6EC6L1NPIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
COCONUT ACID40U37V505DIACT
PEPPERMINT OILAV092KU4JHIACT
ASCORBYL PALMITATEQN83US2B0NIACT
XANTHAN GUMTTV12P4NEEIACT
BENZOIC ACID8SKN0B0MIMIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
POTASSIUM HYDROXIDEWZH3C48M4TIACT

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
Zinc PyrithioneZINC PYRITHIONEHarry's Inc.a4fecf11-dd44-a06e-e053-2995a90afacf2024-12-16WarningsExact identifier
ndc (package): 70533-003-14
ndc (package): 70533-003-02
ndc (product): 70533-003
ndc11 (package): 70533000314
ndc11 (package): 70533000302
spl id: 2969d9c2-ecb2-6f2c-e063-6294a90a34f0
spl set id: a4fecf11-dd44-a06e-e053-2995a90afacf

Reported adverse events (FAERS/openFDA)#

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