OTC - ACTIVE INGREDIENT SECTION
Miconazole Nitrate 1.5%
Update 85398-001-01
- Manufacturer
- Beautivity LLC
- Effective date
- 2026-08-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-08-18 02:01:50
Label at a glance#
ProductFolliculitis Cream
Active ingredientMICONAZOLE NITRATE
Label structure10 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Anti-fungal
INDICATIONS & USAGE SECTION
- Treats most folliculitis, tinea capitis, lichen, and psoriasis.
- Relieves the itching, irritation, redness, scaling and discomfort accompanying thee conditions.
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 thoroughly with water.
keep out of the reach of Children.
OTC - STOP USE SECTION
If irritation occurs or there is no improvement within 4 weeks.
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.
OTHER SAFETY INFORMATION
- Store at 59-85 ºF(15-30 ºC)
- Close the cap tightly after use
INACTIVE INGREDIENT SECTION
Water, Dimethicone, Mineral Oil, Petrolatum, Glycerin, Glyceryl Monostearate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Rhinacanthus nasutus Leaf, Viola philippica Whole, Euphorbia hirta Whole, Murraya paniculata Whole, Mentha haplocalyx Oil, Borneol, Sophora flavescens Root, Cnidium monnieri Fruit, Bassia scoparia Whole, Dictamnus dasycarpus Root Bark, Smilax glabra Tuber, Dianthus superbus Flowering Top, Chlorhexidine Acetate
OTC - QUESTIONS SECTION
contact us at service@hermonhealth.com
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
Products#
Every source-derived product name is available through these pages.
- Folliculitis Cream
- Miconazole Nitrate
- MICONAZOLE
- VIOLA PHILIPPICA WHOLE
- PEPPERMINT
- CNIDIUM MONNIERI FRUIT
- GLYCERYL MONOSTEARATE
- MURRAYA PANICULATA WHOLE
- DIMETHICONE
- BASSIA SCOPARIA WHOLE
- DIANTHUS SUPERBUS FLOWERING TOP
- MINERAL OIL
- SOPHORA FLAVESCENS ROOT
- GLYCERIN
- STEARIC ACID
- DICTAMNUS DASYCARPUS ROOT BARK
- PETROLATUM
- WATER
- RHINACANTHUS NASUTUS LEAF
- SMILAX GLABRA TUBER
- PEG-100 STEARATE
- EUPHORBIA HIRTA
- BORNEOL
- CHLORHEXIDINE ACETATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85398-001 | 85398-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-06-28 | full-release | 2026-06-01 01:08:14 |
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 |
|---|---|---|---|---|---|---|
| Folliculitis Cream | MICONAZOLE NITRATE | Beautivity LLC | 3155dd5e-621b-358e-e063-6294a90a90f8 | 2026-08-13 | Warnings | 85398-001-01 85398-001 85398000101 58f42b88-6f07-46fd-e063-6294a90ad08f 3155dd5e-621b-358e-e063-6294a90a90f8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.