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 Cream 1% ANTIFUNGAL
- Manufacturer
- Trifecta Pharmaceuticals Usa Llc
- Effective date
- 2025-05-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:05
Label at a glance#
ProductTolnaftate Cream 1% ANTIFUNGAL
Active ingredientTOLNAFTATE
Label structure11 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 conditions persists longer, ask a healthcare professional. ● to prevent at...
Storage and handling
● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.
Contacts and useful links#
Websitewww.trifecta-pharma.com
www.trifecta-pharma.com
www.trifecta-pharma.comLabel contents#
Full prescribing information#
Active ingredient
Tolnaftate 1%
Purpose
Anti-Fungal
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 immediately.
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.
When using this product avoid contact with the eyes.
Stop use and ask a healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement
Do not use on children under 2 years of age except under the advice and supervision of a healthcare professional.
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 conditions persists longer, ask a healthcare professional.
● to prevent athlete's foot, apply once or twice daily (morning and/or night)
● this product is not effective on the scalp or nails.
Inactive ingredients
Cetostearyl alcohol, ethylparaben, glycerol, light mineral oil, monostearin, petrolatum, purified water, sodium dodecyl sulfate
Other information
● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.
SPL UNCLASSIFIED SECTION
100% GUARANTEED
Cures and Prevents Most Athlete's Foot
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301 USA
Product of PRC
Packaging
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-016-05 | Tolnaftate Cream 1% ANTIFUNGAL | 1 in 1 BOX | CREAM | 1 | 8 | |
| 69396-016-05 | Tolnaftate Cream 1% ANTIFUNGAL | 15 g in 1 TUBE | CREAM | 15 | 8 | |
| 69396-016-20 | Tolnaftate Cream 1% ANTIFUNGAL | 1 in 1 BOX | CREAM | 1 | 8 | |
| 69396-016-20 | Tolnaftate Cream 1% ANTIFUNGAL | 30 g in 1 TUBE | CREAM | 30 | 8 | |
| 69396-016-33 | Tolnaftate Cream 1% ANTIFUNGAL | 30 g in 1 TUBE | CREAM | 30 | 8 | |
| 69396-016-33 | Tolnaftate Cream 1% ANTIFUNGAL | 3 in 1 BOX | CREAM | 3 | 8 | |
| 69396-016-66 | Tolnaftate Cream 1% ANTIFUNGAL | 30 g in 1 TUBE | CREAM | 30 | 8 | |
| 69396-016-66 | Tolnaftate Cream 1% ANTIFUNGAL | 6 in 1 BOX | CREAM | 6 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69396-016-20 | GM - Gram | 69396-016 | aa3c307b-f4ba-43f9-a916-a7f90c077987 | 1 | 2018-11-06 |
Products#
Every source-derived product name is available through these pages.
- Tolnaftate Cream 1% ANTIFUNGAL
- Tolnaftate
- CETOSTEARYL ALCOHOL
- ETHYLPARABEN
- GLYCERIN
- LIGHT MINERAL OIL
- GLYCERYL MONOSTEARATE
- PETROLATUM
- WATER
- SODIUM LAURYL SULFATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69396-016 | 69396-016-20, 69396-016-05, 69396-016-66, 69396-016-33 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| TOLNAFTATE | 06KB629TKV | 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 |
|---|---|---|---|---|---|---|
| Tolnaftate Cream 1% ANTIFUNGAL | TOLNAFTATE | Trifecta Pharmaceuticals Usa Llc | 96a40ccd-17f7-4e4e-98da-207802fa2b2d | 2025-05-15 | Warnings | 69396-016-66 69396-016-20 69396-016-05 69396-016-33 69396-016 69396001666 69396001620 69396001605 69396001633 352f8de3-8ff3-4098-e063-6294a90ace4d 96a40ccd-17f7-4e4e-98da-207802fa2b2d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.