OTC - ACTIVE INGREDIENT SECTION
Active ingredient Purpose
Tolnaftate 1%-----------------------------------------------------------------------------------------------Antifungal
Active ingredient Purpose
Tolnaftate 1%-----------------------------------------------------------------------------------------------Antifungal
Uses
Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
Helps preent 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
Do not use on children under 2 years of age except under the advice and supervision of a doctor
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Other information
store between 20° to 25° (68° to 77°F)
Lot No. & Exp. Date;see box or see crimp of tube
ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, propylene glycol, purified water, white petrolatum
Distributed by:
First Aid Research Corp.
Wantagh, NY U.S. A. 11793
Made in Korea
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75983-537-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3946-f424-e053-dadaa90a57ce | 635645c5-993f-47fe-871c-6279148f0b9c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75983-537-28 | First Aid Antifungal Medicated Cream 1oz | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 75983-537-28 | First Aid Antifungal Medicated Cream 1oz | 28 g in 1 TUBE | CREAM | 28 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TOLNAFTATE | ACTIVE INGREDIENT | 06KB629TKV | 1 | |
| TOLNAFTATE | ACTIVE MOIETY | 06KB629TKV | 1 | |
| CETETH-20 | INACTIVE INGREDIENT | I835H2IHHX | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CHLOROCRESOL | INACTIVE INGREDIENT | 36W53O7109 | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | INACTIVE INGREDIENT | 5QWK665956 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75983-537 | 75983-537-28 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TOLNAFTATE | 06KB629TKV | ACTIB |
| CETETH-20 | I835H2IHHX | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CHLOROCRESOL | 36W53O7109 | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| CHLOROCRESOL | CHLOROCRESOL | 36W53O7109 | CREAM, AUGMENTED / TOPICAL | 0.1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | SOLUTION/ DROPS / OPHTHALMIC | 1.15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| CETETH-20 | CETETH-20 | I835H2IHHX | CREAM / TOPICAL | 429 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 1.6 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYSTEM / TOPICAL | 4200 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SUPPOSITORY / VAGINAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CREAM / TOPICAL | 300 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, EXTENDED RELEASE / ORAL | 321 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET / ORAL | 0.7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | TABLET, EXTENDED RELEASE / ORAL | 800 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION, SOLUTION / INTRAVENOUS | 115 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / TOPICAL | 2860 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION / SUBCUTANEOUS | 0.3 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w |
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 |
|---|---|---|---|---|---|---|
| c7319ee5-9106-4f5c-b9e0-1d5cb5e0cc7b | 635645c5-993f-47fe-871c-6279148f0b9c | 2014-10-09 | Warnings | c7319ee5-9106-4f5c-b9e0-1d5cb5e0cc7b 635645c5-993f-47fe-871c-6279148f0b9c |
Adverse event summaries are temporarily unavailable. Other product information remains available.