Indications and uses
proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching, burning and cracking
Tolnaftate Antifungal Cream 1%
- Manufacturer
- Central Texas Community Health Centers | Travis County Healthcare District
- Effective date
- 2018-05-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:55:19
Label at a glance#
ProductTolnaftate Antifungal
Active ingredientTOLNAFTATE
Label structure12 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 shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twi...
Storage and handling
store between 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Tolnaftate 1%
Purpose
Antifungal
Uses
- proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
- helps prevent most athlete's foot with daily use
- for effective relief of itching, burning and cracking
Warnings
For external use only
OTC - WHEN USING SECTION
When using this product avoid contact with eyes
OTC - STOP USE SECTION
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks
OTC - DO NOT USE SECTION
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
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 shoes and socks at least once daily
- use daily for 4 weeks; if condition persists longer, ask a doctor
- to prevent athlete's foot, apply once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails
Other information
- store between 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive ingredients
BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum
Questions?
Call 1-866-923-4914
SPL UNCLASSIFIED SECTION
Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
HOW SUPPLIED
Product: 76413-321
NDC: 76413-321-15 15 g in a TUBE
TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-321-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-250c-f424-e053-dadaa90a57ce | Tolnaftate Antifungal Cream 1% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-321-15 | Tolnaftate Antifungal | 15 g in 1 TUBE | CREAM | 15 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-2020-1 | GM - Gram | 51672-2020 | 3065f191-8b9f-462a-aab4-d7476df3a571 | 1 | 2013-02-13 |
| 51672-2020-2 | GM - Gram | 51672-2020 | a24f5108-1a7f-4f7a-b78f-586f6403fb3c | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Tolnaftate Antifungal
- Tolnaftate
- butylated hydroxytoluene
- polyethylene glycol 400
- polyethylene glycol 3350
- titanium dioxide
- petrolatum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76413-321 | 76413-321-15 |
| 51672-2020 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TOLNAFTATE | 06KB629TKV | ACTIB |
| butylated hydroxytoluene | 1P9D0Z171K | IACT |
| polyethylene glycol 400 | B697894SGQ | IACT |
| polyethylene glycol 3350 | G2M7P15E5P | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
| petrolatum | 4T6H12BN9U | IACT |
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 |
|---|---|---|---|---|---|---|
| Tolnaftate Antifungal | TOLNAFTATE | Sun Pharmaceutical Industries, Inc. | fa16fa08-fbbd-4f45-b64a-9bffe78e8861 | 2025-07-01 | Warnings | 51672-2020 |
| 84b31d3c-7651-40d6-a11b-d21756fcb85e | 2b2303dd-fec2-4ff4-a0ae-6bfb921dd246 | 2018-05-01 | Warnings | 84b31d3c-7651-40d6-a11b-d21756fcb85e 2b2303dd-fec2-4ff4-a0ae-6bfb921dd246 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.