Naftifine Hydrochloride Cream USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .
A sufficient quantity of Naftifine Hydrochloride Cream USP, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Cream USP, 1%, the patient should be re-evaluated.
Rx ONLY
Naftifine Hydrochloride Cream USP, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Cream USP, 1% is for topical use only.
CHEMICAL NAME:
(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride. Naftifine hydrochloride has an empirical formula of C 21H 21N∙HCl and a molecular weight of 323.86.
Structural Formula
|
| naftifine hydrochloride |
Contains
Active Ingredient
Naftifine hydrochloride 1%
Inactive Ingredients
benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH.
Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitrodata are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitroagainst a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini,and Microsporum gypseum;and fungistatic activity against Candidaspecies, including Candida albicans. Naftifine Hydrochloride Cream USP, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE section.
Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.
In vitroand in vivobioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes.
Following a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.
Naftifine Hydrochloride Cream USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes,and Epidermophyton floccosum.
Naftifine Hydrochloride Cream USP, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.
Naftifine Hydrochloride Cream USP, 1% is for topical use only and not for ophthalmic use.
Naftifine Hydrochloride Cream USP, 1% is for external use only. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream USP, 1%, treatment should be discontinued and appropriate therapy instituted.
Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.
The patient should be told to:
In a 2-year dermal carcinogenicity study, naftifine hydrochloride cream was administered to Sprague-Dawley rats at topical doses of 1%, 2% and 3% (10 mg/kg/day, 20 mg/kg/day, and 30 mg/kg/day naftifine hydrochloride). No drug-related tumors were noted in this study up to the highest dose evaluated in this study of 30 mg/kg/day [3.6 times the maximum recommended human dose (MRHD) based on mg/m 2comparison].
Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitrogenotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivogenotoxicity test (mouse bone marrow micronucleus assay).
Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 100 mg/kg/day (12 times MRHD based on mg/m 2comparison).
Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftifine Hydrochloride Cream USP, 1% is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
During clinical trials with Naftifine Hydrochloride Cream USP, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%).
A sufficient quantity of Naftifine Hydrochloride Cream USP, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Cream USP, 1%, the patient should be re-evaluated.
Naftifine Hydrochloride Cream USP, 1% is supplied in the following sizes:
15 g - NDC 51672-1362-1 (tube)
30 g - NDC 51672-1362-2 (tube)
60 g - NDC 51672-1362-3 (tube)
90 g - NDC 51672-1362-8 (tube)
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
Manufactured by:
Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Distributed by:
Taro Pharmaceuticals U.S.A., Inc.,Hawthorne, NY 10532
TARO is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.
Revised: May 2018
PK-7357-2 10
NDC 51672-1362-8
90 g
Naftifine Hydrochloride
Cream USP, 1%
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx only
TARO
Keep this and all medications out of the reach of children.
| Class | Version | Type | Effective |
|---|---|---|---|
| NAFTIFINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8f630d5a-8a28-4ac5-8ede-8b54b7617055 | Product name | 3 | 20210512 |
| 6aca302d-6492-4ac9-8829-e023cb64c91c | Product name | 1 | 20190627 |
| ba2e3195-29b1-b94a-4345-149632e97b51 | Product name | 3 | 20161117 |
| 7ac69d99-c06d-0e83-7872-6229bc9878f9 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-1362-1 | Naftifine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 51672-1362-1 | Naftifine Hydrochloride | 15 g in 1 TUBE | CREAM | 15 | 3 | |
| 51672-1362-2 | Naftifine Hydrochloride | 30 g in 1 TUBE | CREAM | 30 | 3 | |
| 51672-1362-2 | Naftifine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 51672-1362-3 | Naftifine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 51672-1362-3 | Naftifine Hydrochloride | 60 g in 1 TUBE | CREAM | 60 | 3 | |
| 51672-1362-8 | Naftifine Hydrochloride | 90 g in 1 TUBE | CREAM | 90 | 3 | |
| 51672-1362-8 | Naftifine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-1362-3 | GM - Gram | 51672-1362 | 36a9aab6-5a08-449f-9e00-1c6868eb25d5 | 1 | 2017-03-06 |
| 51672-1362-8 | GM - Gram | 51672-1362 | 9d8249c0-21a8-45d3-9e5b-b13785221f70 | 1 | 2017-03-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51672-1362 | 51672-1362-1, 51672-1362-2, 51672-1362-3, 51672-1362-8 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| CETYL ESTERS WAX | D072FFP9GU | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| NAFTIFINE HYDROCHLORIDE | 25UR9N9041 | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205975-001 | NAFTIFINE HYDROCHLORIDE | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A205975-001 | NAFTIFINE HYDROCHLORIDE | 1% | CREAM / TOPICAL | RS | 2016-09-08 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Naftifine Hydrochloride | NAFTIFINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | d50961c2-e97f-4583-91d6-7cafd25a8c3d | 2025-07-07 | Warnings, Adverse reactions | 51672-1362-3 51672-1362-1 51672-1362-8 51672-1362-2 51672-1362 51672136208 51672136202 51672136203 51672136201 39620da3-e660-e94f-e063-6294a90afd69 d50961c2-e97f-4583-91d6-7cafd25a8c3d |
Adverse event summaries are temporarily unavailable. Other product information remains available.
