Indications and uses
to help prevent recurrence of flaking and itching associated with dandruff.
DANDRUFF
- Manufacturer
- TOPCO ASSOCIATES LLC | APOLLO HEALTH AND BEAUTY CARE INC.
- Effective date
- 2017-06-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:51:40
Label at a glance#
ProductDANDRUFF
Active ingredientPYRITHIONE ZINC
Label structure6 sections
Dosage and administration
for maximum dandruff control, use every time you shampoo. wet hair, massage onto scalp and rinse. repeat if desired.
Label contents#
Full prescribing information#
Active ingredient
Pyrithione zinc 1%
Purpose
Anti-dandruff
Uses
to help prevent recurrence of flaking and itching associated with dandruff.
Warnings
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.
Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Directions
- for maximum dandruff control, use every time you shampoo.
- wet hair, massage onto scalp and rinse.
- repeat if desired.
Inactive ingredients
Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Glycol Distearate, Zinc Carbonate, Sodium Xylenesulfonate, Cocamidopropyl Betaine, Dimethicone, Fragrance (Parfum), Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Magnesium Sulfate, Benzyl Alcohol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).
Label Copy
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0036800410589 | GTIN-13: 0036800410589 EAN-13: 0036800410589 GTIN-12: 036800410589 UPC-A: 036800410589 GTIN storage (14 digits): 00036800410589 | 20237L.jpg |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-309-13 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5558-a910-e053-dadaa90a0b85 | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-309-13 | DANDRUFF | 420 mL in 1 BOTTLE, PLASTIC | SHAMPOO | 420 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- DANDRUFF
- Pyrithione zinc
- WATER
- SODIUM LAURETH SULFATE
- SODIUM CHLORIDE
- GLYCOL DISTEARATE
- ZINC CARBONATE
- SODIUM XYLENESULFONATE
- COCAMIDOPROPYL BETAINE
- DIMETHICONE
- SODIUM BENZOATE
- GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
- MAGNESIUM CARBONATE HYDROXIDE
- MAGNESIUM SULFATE, UNSPECIFIED
- BENZYL ALCOHOL
- CITRIC ACID MONOHYDRATE
- METHYLCHLOROISOTHIAZOLINONE
- METHYLISOTHIAZOLINONE
- FD&C BLUE NO. 1
- D&C RED NO. 33
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-309 | 36800-309-13 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 45a19ba9-5ae9-4b2e-be37-86aae170f35b | 8c155d34-6d19-4b89-b83e-1330453d0c6e | 2017-06-20 | Warnings | 45a19ba9-5ae9-4b2e-be37-86aae170f35b 8c155d34-6d19-4b89-b83e-1330453d0c6e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.