OTC - ACTIVE INGREDIENT SECTION
ketoconazole 1%
1% ketoconazole
- Manufacturer
- TAGRID LLC
- Effective date
- 2025-03-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-06-18 05:10:15
Label at a glance#
Product1% ketoconazole
Active ingredientKETOCONAZOLE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Anti Dandruff
INDICATIONS & USAGE SECTION
- Targets Stubborn Dandruff, Seborrheic Dermatitis, and itching
- Prevention, Treatment, and control of fungus that can cause dandruff
WARNINGS SECTION
For external use only
OTC - DO NOT USE SECTION
on the scalp that is broken or inflamed if you are allergic to ingredients in this product
OTC - WHEN USING SECTION
do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
OTC - STOP USE SECTION
If the rash appears or the condition worsens does not improve in 2-4 weeks.
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a doctor before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Posion Control Center immediately
DOSAGE & ADMINISTRATION SECTION
adults and children
12 years and over
• wet hair thoroughly
• apply shampoo, generously lather, rinse thoroughly. Repeat
• use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff
Children under 12 years old • Ask a doctor
OTHER SAFETY INFORMATION
• store at 20°C to 25°C (68°F-77°F)
• see top panel for lot number and expiration date
OTC - QUESTIONS SECTION
Support@tagridllc.com
INACTIVE INGREDIENT SECTION
Citric Acid, Herba Violae, Euphorbia Hirta, Murraya Paniculata ,Mentha Canadensis, Sophora Flavescens, Dittany Bark, Glabrous Greenbrier Rhizome, Mosla Cavaleriei Levl ,Stellera Chamaejasme, Huang Bai, Sessile Stemona Root, Gleditsia Sinensis, Common Cnidium Fruit, Fructus Kochiae, Tea Tree Oil, Water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5 | Product name | 2 | 20250331 |
| 1e18fb2e-aeff-8efe-93be-5a5f7be8faa2 | Product name | 2 | 20211209 |
| 8bc3781f-20ed-678b-44a7-a981e693c65f | Product name | 2 | 20211209 |
| ff3a8c91-648c-300b-467e-10703f514265 | Product name | 2 | 20180809 |
| 152a96a4-36b6-f5b1-d4e6-9a500e06bbf3 | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- 1% ketoconazole
- Ketoconazole
- PHELLODENDRON AMURENSE BARK
- STEMONA SESSILIFOLIA ROOT
- GLEDITSIA SINENSIS THORN
- CNIDIUM MONNIERI FRUIT
- MURRAYA PANICULATA ROOT BARK
- DICTAMNUS DASYCARPUS ROOT BARK
- STELLERA CHAMAEJASME WHOLE
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- CITRIC ACID
- SMILAX GLABRA TUBER
- WATER
- SOPHORA FLAVESCENS ROOT
- MENTHA CANADENSIS TOP OIL
- EUPHORBIA HIRTA
- MOSLA CAVALERIEI WHOLE
- VIOLA YEZOENSIS WHOLE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85384-0001 | 85384-0001-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-03-19 | full-release | 2026-06-01 00:58:07 |
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 |
|---|---|---|---|---|---|---|
| 1% ketoconazole | KETOCONAZOLE | TAGRID LLC | 30b75584-3a1e-c125-e063-6294a90acaa7 | 2025-03-19 | Warnings | 85384-0001-1 85384-0001 85384000101 1b9d0aa4-ace1-48b8-a76f-ddf34c238320 30b75584-3a1e-c125-e063-6294a90acaa7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.