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
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:47:37
Label at a glance#
ProductTolnaftate Cream 1% ANTIFUNGAL
Active ingredientTOLNAFTATE
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 shoes and socks at least once daily. ● use daily for 4 weeks; if conditions persists longer, ask a doctor. ● to prevent athlete's foot, app...
Storage and handling
● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.
Label contents#
Full prescribing information#
Active ingredient
Tolnaftate 1%
Purpose
Anti-Fungal
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 doctor.
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 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.
Inactive ingredients
Cetyl alcohol, ethylparaben, glycerol, light mineral oil, glycerol monostearate, 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
DISTRIBUTED BY: MIDWOOD BRANDS, LLC.
500 VOLVO PARKWAY, CHESAPEAKE, VA. 23320
NOT SATISFIED?
Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.
This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin®
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-042-05 | Tolnaftate Cream 1% ANTIFUNGAL | 1 in 1 BOX | CREAM | 1 | 5 | |
| 69396-042-05 | Tolnaftate Cream 1% ANTIFUNGAL | 15 g in 1 TUBE | CREAM | 15 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Tolnaftate Cream 1% ANTIFUNGAL
- Family Wellness Tolnaftate
- ETHYLPARABEN
- GLYCERIN
- LIGHT MINERAL OIL
- GLYCERYL MONOSTEARATE
- PETROLATUM
- WATER
- SODIUM DODECYLBENZENESULFONATE
- TOLNAFTATE
- CETYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69396-042 | 69396-042-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ETHYLPARABEN | 14255EXE39 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM DODECYLBENZENESULFONATE | 554127163Y | IACT |
| TOLNAFTATE | 06KB629TKV | ACTIB |
| CETYL ALCOHOL | 936JST6JCN | 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 Cream 1% ANTIFUNGAL | FAMILY WELLNESS TOLNAFTATE | Trifecta Pharmaceuticals USA, LLC | 915759af-0d7f-6a87-e053-2a95a90acbd6 | 2024-12-20 | Warnings | 69396-042-05 69396-042 69396004205 29b3b3a6-1e40-3efa-e063-6294a90a15c2 915759af-0d7f-6a87-e053-2a95a90acbd6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.