DOSAGE & ADMINISTRATION SECTION
For maximum dandruff control, use every time you shampoo.
Wet hair, massage unto scalp, rinse, and repeat if desired.
For best results use at least twice a week or as directed by a doctor.
PYRITHIONE ZINC
- Manufacturer
- BRANDS INTERNATIONAL
- Effective date
- 2023-08-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:55:49
Label at a glance#
ProductPYRITHIONE ZINC
Active ingredientPYRITHIONE ZINC
Label structure10 sections
Label contents#
Full prescribing information#
WARNINGS SECTION
For external use only.
INACTIVE INGREDIENT SECTION
Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Aloe vera Leaf Extract, Parfum, Vitamin E, Methylchloroisothiazolinone,Methylisothiazolinone, FD&C Blue#1 ,FD&C Red#33.
INDICATIONS & USAGE SECTION
Helps prevent recurrence of flaking and itching associated with dandruff.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out of children’s reach.
OTC - PURPOSE SECTION
Anti-dandruff
OTC - ACTIVE INGREDIENT SECTION
Pyrithione Zinc 0.3%
OTC - STOP USE SECTION
Condition worsens or does not improve after regular use of this product as directed
OTC - WHEN USING SECTION
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50157-125-10 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5ba3-d83d-e063-dadaa90ab31f | Next Gen Dandruff Shampoo |
| 50157-125-35 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5ba3-d83d-e063-dadaa90ab31f | Next Gen Dandruff Shampoo |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50157-125-10 | PYRITHIONE ZINC | 295 mL in 1 BOTTLE | SHAMPOO | 295 | 3 | |
| 50157-125-35 | PYRITHIONE ZINC | 355 mL in 1 BOTTLE | SHAMPOO | 355 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- PYRITHIONE ZINC
- WATER
- SODIUM CHLORIDE
- GLYCOL DISTEARATE
- EDETATE SODIUM
- ALOE VERA LEAF
- D&C RED NO. 33
- BASIC BLUE 1
- .ALPHA.-TOCOPHEROL
- COCAMIDOPROPYL BETAINE
- METHYLISOTHIAZOLINONE
- SODIUM LAURYL SULFATE
- METHYLCHLOROISOTHIAZOLINONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50157-125 | 50157-125-10, 50157-125-35 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| GLYCOL DISTEARATE | 13W7MDN21W | IACT |
| EDETATE SODIUM | MP1J8420LU | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| BASIC BLUE 1 | 92N74OA24D | IACT |
| .ALPHA.-TOCOPHEROL | H4N855PNZ1 | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| METHYLISOTHIAZOLINONE | 229D0E1QFA | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| METHYLCHLOROISOTHIAZOLINONE | DEL7T5QRPN | IACT |
| PYRITHIONE ZINC | R953O2RHZ5 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 021dabae-fd63-b5a6-e063-6294a90ac2aa | e65f69d2-233f-9ebf-e053-2995a90a720e | 2023-08-04 | Warnings | 021dabae-fd63-b5a6-e063-6294a90ac2aa e65f69d2-233f-9ebf-e053-2995a90a720e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.