Storage and handling
Store at room temperature. Protect from excessive heat (above 104ºF/40ºC)
Update-85398-002-01
- Manufacturer
- Beautivity LLC
- Effective date
- 2026-06-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:37:06
Label at a glance#
ProductTinea Versicolor Treatment Cream
Active ingredientCLOTRIMAZOLE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Clotrimazole 1%
OTC - PURPOSE SECTION
Antifungal
INDICATIONS & USAGE SECTION
Helps relieve & prevent itching, burning, cracking, and scaling associated with tinea nersicolor infections.
WARNINGS SECTION
For External Use Only
OTC - DO NOT USE SECTION
it on children under 2 years of age unless directed by a doctor.
OTC - WHEN USING SECTION
avoid contact with eyes, if contact occurs, rinse the eyes very thoroughly with water.
OTC - STOP USE SECTION
Stop Using and Ask a Physician if irritation occurs or there is no improvement within 4 weeks.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
keep out of the reach of young children.
DOSAGE & ADMINISTRATION SECTION
- Wash the affected area and dry thoroughly.
- Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor, supervise children in the use of the product.
- If the condition persists longer, consult a doctor.
STORAGE AND HANDLING SECTION
Store at room temperature. Protect from excessive heat (above 104ºF/40ºC)
INACTIVE INGREDIENT SECTION
Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil
OTC - QUESTIONS SECTION
service@hermonhealth.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Tinea Versicolor Treatment Cream
- Clotrimazole
- WATER
- PEPPERMINT OIL
- CAMPHOR (SYNTHETIC)
- TRIETHANOLAMINE
- GLYCERIN
- PROPYLENE GLYCOL
- METHYLPARABEN
- GENTIANA LUTEA ROOT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85398-002 | 85398-002-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| CAMPHOR (SYNTHETIC) | 5TJD82A1ET | IACT |
| TRIETHANOLAMINE | 9O3K93S3TK | IACT |
| CLOTRIMAZOLE | G07GZ97H65 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| GENTIANA LUTEA ROOT | S72O3284MS | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-03-02 | full-release | 2026-06-01 01:48:19 |
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 |
|---|---|---|---|---|---|---|
| Tinea Versicolor Treatment Cream | CLOTRIMAZOLE | Beautivity LLC | 32d71d7e-3c78-6b63-e063-6294a90adaed | 2026-06-29 | Warnings | 85398-002-01 85398-002 85398000201 5566ae2e-a723-421a-e063-6394a90ac026 32d71d7e-3c78-6b63-e063-6294a90adaed |
| Tinea Versicolor Treatment Kit | CLOTRIMAZOLE | Beautivity LLC | 3361d9a2-daf6-7749-e063-6294a90a3653 | 2026-06-29 | Warnings | 85398-002-01 85398000201 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.