Indications and uses
cures most athlete's foot, jock itch and ringworm relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Astonea Clotrimazole 1%
- Manufacturer
- ASTONEA LABS PRIVATE LIMITED
- Effective date
- 2024-06-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:14:17
Label at a glance#
ProductAstonea Clotrimazole 1% Athletes Foot
Active ingredientCLOTRIMAZOLE
Label structure9 sections
Dosage and administration
wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks if condition persists longe...
Storage and handling
store between 20° - 25°C (68° - 77°F) see carton or tube crimp for lot number and expiration date
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Clotrimazole 1% (w/w)
Purpose
Antifungal
Uses
- cures most athlete's foot, jock itch and ringworm
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use on children under 2 years of age unless directed by a doctor.
OTC - WHEN USING SECTION
When using this product
- avoid contact with eyes.
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- if condition persists longer, ask a doctor
- this product is not effective on the scalp or nails
Other information
- store between 20° - 25°C (68° - 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive ingredients
Ceteth-20, Cetostearyl Alcohol, Chorocresol, Edetate Disodium, Light Mineral Oil, Propylene Glycol, Sodium Metabisulfite,Water
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CLOTRIMAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
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 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77338-312-44 | 2024-06-25 | C162847 | 48780-1 | 1030e365-4d59-111a-e063-dadaa90a10e2 | Astonea Clotrimazole USP, 1% |
| 77338-312-48 | 2024-06-25 | C162847 | 48780-1 | 1030e365-4d59-111a-e063-dadaa90a10e2 | Astonea Clotrimazole USP, 1% |
| 77338-312-44 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4d59-111a-e063-dadaa90a10e2 | Astonea Clotrimazole USP, 1% |
| 77338-312-48 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4d59-111a-e063-dadaa90a10e2 | Astonea Clotrimazole USP, 1% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77338-312-44 | Astonea Clotrimazole 1%Athletes Foot | 28.3 g in 1 TUBE | CREAM | 28.3 | 3 | |
| 77338-312-48 | Astonea Clotrimazole 1%Athletes Foot | 113 g in 1 TUBE | CREAM | 113 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Astonea Clotrimazole 1% Athletes Foot
- Clotrimazole
- SODIUM METABISULFITE
- BISULFITE ION
- PROPYLENE GLYCOL
- CETETH-20
- CETOSTEARYL ALCOHOL
- EDETATE DISODIUM
- EDETIC ACID
- WATER
- CHLOROCRESOL
- LIGHT MINERAL OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77338-312 | 77338-312-44, 77338-312-48 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CETETH-20 | I835H2IHHX | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| WATER | 059QF0KO0R | IACT |
| CHLOROCRESOL | 36W53O7109 | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| CLOTRIMAZOLE | G07GZ97H65 | 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 |
|---|---|---|---|---|---|---|
| 1bbb0211-ebfc-bdeb-e063-6294a90af56a | e5d2b45a-26f2-14a9-e053-2a95a90a2456 | 2024-06-25 | Warnings | 1bbb0211-ebfc-bdeb-e063-6294a90af56a e5d2b45a-26f2-14a9-e053-2a95a90a2456 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.