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.
Quality Choice Antifungal Cream Tolnaftate 1%
- Manufacturer
- Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA, LLC.
- Effective date
- 2023-05-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:55:03
Label at a glance#
ProductAntifungal
Active ingredientTOLNAFTATE
Label structure10 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.qualitychoice.com
www.qualitychoice.com
www.qualitychoice.comLabel contents#
Full prescribing information#
Active ingredient
Tolnaftate 1%
Purpose
Antifungal
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 doctorl 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, mineral oil, glycerol monostearate, petrolatum, purified water, sodium lauryl sulfate
Other information
● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.
Distributed By
Distributed By CDMA Inc.
43157 W 9 Mile Road
Novi, MI. 48375
Questions: 800-935-2362
Product of PRC
This product is not manufactured or distributed by Bayer Health Care, LLC. distributor of Tinactin Antifungal Cream
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63868-685-01 | 2025-01-30 | C162847 | 48780-1 | f386c64a-1fd0-0266-e053-dadaa90a7c1a | Quality Choice Antifungal Cream Tolnaftate 1% |
| 63868-685-01 | 2023-05-23 | C162847 | 48780-1 | f386c64a-1fd0-0266-e053-dadaa90a7c1a | Quality Choice Antifungal Cream Tolnaftate 1% |
| 63868-685-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1fd0-0266-e053-dadaa90a7c1a | Quality Choice Antifungal Cream Tolnaftate 1% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-685-01 | Antifungal | 28.3 g in 1 TUBE | CREAM | 28.3 | 3 | |
| 63868-685-01 | Antifungal | 1 in 1 BOX | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-685-01 | GM - Gram | 63868-685 | a4ac303e-039c-44b5-8dc1-ebc77d05876a | 1 | 2022-09-12 |
Products#
Every source-derived product name is available through these pages.
- Antifungal
- Tolnaftate 1%
- MINERAL OIL
- ETHYLPARABEN
- GLYCERIN
- SODIUM LAURYL SULFATE
- GLYCERYL MONOSTEARATE
- PETROLATUM
- WATER
- CETYL ALCOHOL
- TOLNAFTATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63868-685 | 63868-685-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| CETYL ALCOHOL | 936JST6JCN | 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 |
|---|---|---|---|---|---|---|
| fc5f2212-8ecb-e4c8-e053-6394a90a7483 | acdbebf1-319d-dfe9-e053-2995a90ad430 | 2023-05-23 | Warnings | fc5f2212-8ecb-e4c8-e053-6394a90a7483 acdbebf1-319d-dfe9-e053-2995a90ad430 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.