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
- CARDINAL HEALTH 110 dba LEADER | Trifecta Pharmaceuticals USA LLC
- Effective date
- 2025-12-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:19:29
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 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.
Contacts and useful links#
Websitewww.myleader.com
www.myleader.com
www.myleader.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 (1-800-222-1222) right away.
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 doctor if ● irritation occurs ● there is no improvement within 4 weeks
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
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.
Questions or Comments?
1-888-296-9067
Distributed By
Distrubuted By Cardinal Health
Dublin, Ohio 43017
1-800-200-6313
Essential to Care since 1979
Made in China
2021 Cardinal Health. All rights reserved Cardinal Health, the Cardinal Health LOGO, ESSENTIAL TO CARE and Leader LOGO are trademarks or registered Trademarks of Cardinal Health. All other marks are the property of their respective owners.
All Leader Brand products have a 100% Money Back Guarantee
This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin.
Packaging
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0096295140682 | GTIN-13: 0096295140682 EAN-13: 0096295140682 GTIN-12: 096295140682 UPC-A: 096295140682 GTIN storage (14 digits): 00096295140682 | CAH LDR Antifungal Cream 1oz.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70000-0084-1 | Tolnaftate Cream 1% ANTIFUNGAL | 30 g in 1 TUBE | CREAM | 30 | 5 | |
| 70000-0084-1 | Tolnaftate Cream 1% ANTIFUNGAL | 1 in 1 BOX | CREAM | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0084-1 | GM - Gram | 70000-0084 | 597afb0c-37c8-4246-94c8-a631ae14cabf | 1 | 2022-02-07 |
Products#
Every source-derived product name is available through these pages.
- Tolnaftate Cream 1% ANTIFUNGAL
- Tolnaftate
- CETYL ALCOHOL
- ETHYLPARABEN
- GLYCERIN
- MINERAL OIL
- GLYCERYL MONOSTEARATE
- PETROLATUM
- WATER
- SODIUM LAURYL SULFATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0084 | 70000-0084-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETYL ALCOHOL | 936JST6JCN | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MINERAL OIL | T5L8T28FGP | 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 | CARDINAL HEALTH 110 dba LEADER | bb14825c-518d-bfba-e053-2995a90a7889 | 2025-12-02 | Warnings | 70000-0084-1 70000-0084 70000008401 44fdb0db-edec-07fd-e063-6394a90a67cb bb14825c-518d-bfba-e053-2995a90a7889 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.