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Naftifine: Pediatric drug information

Naftifine: Pediatric drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Naftifine: Drug information" and "Naftifine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Naftin
Therapeutic Category
  • Antifungal Agent, Topical
Dosing: Pediatric
Tinea corporis

Tinea corporis (ringworm): Children ≥2 years and Adolescents: Cream 2%: Topical: Apply to affected and surrounding area(s) once daily until clinical resolution; typically 2 weeks.

Tinea cruris

Tinea cruris (jock itch): Children ≥12 years and Adolescents: Cream 2%: Topical: Apply to affected and surrounding area(s) once daily until clinical resolution; typically 2 weeks.

Tinea pedis

Tinea pedis (athlete's foot): Children ≥12 years and Adolescents: Topical: Gel 2%, Cream 2%: Topical: Apply to affected and surrounding area(s) once daily until clinical resolution; typically 2 to 4 weeks (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Naftifine: Drug information")

Tinea infection

Tinea infection:

Tinea corporis/tinea cruris: Topical:

Cream 1% and 2%, gel 1%: Apply to affected and surrounding area(s) once daily (cream) or twice daily (gel) until clinical resolution, typically 1 to 4 weeks; resolution may be faster with 2% cream (Ref).

Tinea pedis (labeled use)/tinea manuum (off-label use): Topical:

Cream 1% and 2%, gel 1% and 2%: Apply to affected and surrounding area(s) once daily (cream and 2% gel) or twice daily (1% gel) until 1 week after clinical resolution, typically for 2 to 4 weeks total; resolution may be faster with 2% formulations (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Burning sensation of skin (5% to 6%), xeroderma (3%), skin irritation (2%), erythema (≤2%), pruritus (1% to 2%)

Local: Application site reaction (2%)

<1%, postmarketing, and/or case reports: Agranulocytosis, crusted skin, dizziness, headache, inflammation, leukopenia, maceration, pain, rash, serous drainage, skin blister, skin tenderness, swelling of skin

Contraindications

Hypersensitivity to naftifine or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: Discontinue if sensitivity or irritation occurs and institute appropriate therapy.

Other warnings/precautions:

• Appropriate use: For topical use only; not intended for oral, ophthalmic, or vaginal use. Avoid use of occlusive dressings and contact with eyes, nose, mouth, or mucous membranes.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as hydrochloride:

Generic: 1% (60 g, 90 g); 2% (45 g, 60 g)

Gel, External, as hydrochloride:

Naftin: 1% (40 g [DSC], 60 g [DSC], 90 g [DSC]) [contains alcohol, usp, edetate (edta) disodium, polysorbate 80]

Naftin: 2% (45 g, 60 g) [contains alcohol, usp, benzyl alcohol, edetate (edta) disodium, propylene glycol, trolamine (triethanolamine)]

Generic: 1% (40 g [DSC], 60 g [DSC], 90 g [DSC]); 2% (45 g, 60 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Naftifine HCl External)

1% (per gram): $6.26

2% (per gram): $8.88

Gel (Naftifine HCl External)

2% (per gram): $11.30

Gel (Naftin External)

2% (per gram): $13.58

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

Topical: Cream 2%, Gel 2%: For topical use only; avoid nasal, ophthalmic, oral, or intravaginal use. Wash hands before and after use. Apply to clean, dry skin. Apply to the affected area(s) and a 1/2-inch margin of healthy surrounding tissue. Avoid occlusive dressings.

Administration: Adult

Topical: For topical use only; avoid nasal, ophthalmic, oral or intravaginal use. Wash hands before and after use. Apply to clean, dry skin. Avoid occlusive dressings.

Storage/Stability

Cream 1%: Store below 30°C (86°F).

Cream 2%, gel 2%: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Gel 1%: Store at room temperature.

Use

Gel 2%: Topical treatment of interdigital tinea pedis (FDA approved in ages ≥12 years and adults).

Cream 2%: Topical treatment of tinea corporis (FDA approved in ages ≥2 years and adults); topical treatment of tinea cruris and interdigital tinea pedis (FDA approved in ages ≥12 years and adults).

Cream 1%: Topical treatment of tinea cruris, tinea corporis, and tinea pedis (FDA approved in adults).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

There are no known significant interactions.

Pregnancy Considerations

Naftifine is absorbed systemically (4% to 6%) following topical administration. Application over a limited area is considered likely acceptable during pregnancy (Patel 2017).

Monitoring Parameters

Monitor application site for irritation or sensitivity.

Mechanism of Action

Synthetic, broad-spectrum antifungal agent in the allylamine class; appears to have both fungistatic and fungicidal activity. Exhibits antifungal activity by selectively inhibiting the enzyme squalene epoxidase in a dose-dependent manner which results in a reduced synthesis of ergosterol, the primary sterol within the fungal membrane, and increased squalene in cells.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Systemic: Cream: 6%; Gel: 4%

Half-life elimination: 2 to 3 days

Excretion: Urine and feces (as unchanged drug and/or metabolites)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Exoderil;
  • (AT) Austria: Exoderil;
  • (BD) Bangladesh: T cure;
  • (BF) Burkina Faso: Exoderil;
  • (BG) Bulgaria: Exoderil;
  • (CH) Switzerland: Exoderil;
  • (CN) China: Xin xin;
  • (CO) Colombia: Exoderil;
  • (CZ) Czech Republic: Exoderil;
  • (DE) Germany: Exoderil;
  • (DO) Dominican Republic: Exoderil;
  • (EC) Ecuador: Exoderil;
  • (EE) Estonia: Exoderil;
  • (EG) Egypt: Exoderil;
  • (ES) Spain: Micosona;
  • (GR) Greece: Exoderil;
  • (HK) Hong Kong: Exoderil | Lonaderm;
  • (HR) Croatia: Exoderil;
  • (HU) Hungary: Exoderil;
  • (ID) Indonesia: Exoderil;
  • (IL) Israel: Exodril;
  • (IN) India: Naftifast;
  • (IT) Italy: Suadian;
  • (JO) Jordan: Exoderil;
  • (KE) Kenya: Exoderil;
  • (KR) Korea, Republic of: Baretoc | Exoderil | Il yang naftifine hcl | Nafgen | Nafnal | Naftin | Nafzol | Naphri | Ramidipine;
  • (KW) Kuwait: Exoderil;
  • (LB) Lebanon: Exoderil;
  • (LT) Lithuania: Exoderil | Fetimin;
  • (LV) Latvia: Exoderil | Fetimin;
  • (MA) Morocco: Exoderil;
  • (MY) Malaysia: Exoderil;
  • (PK) Pakistan: Exoderil;
  • (PL) Poland: Exoderil;
  • (PR) Puerto Rico: Naftifine HCL | Naftin;
  • (QA) Qatar: Exoderil;
  • (RO) Romania: Exoderil;
  • (RU) Russian Federation: Exoderil | Exohelp | Exostat | Mycoderil | Naftifine | Naftoderil;
  • (SA) Saudi Arabia: Exoderil;
  • (SG) Singapore: Exoderil;
  • (SI) Slovenia: Exoderil;
  • (SK) Slovakia: Exoderil;
  • (TR) Turkey: Dermifin | Exelderm | Exifin | Exoderil | Funderyl | Nafderilex | Naxoder;
  • (TW) Taiwan: Ancent | Anzumei | Chizocin | Decent | Exoderil | Genaf | Jia Mei | Kafutinea | Nafdin | Naftifine | Natifim | Tifin;
  • (UA) Ukraine: Eczo tifin | Estezifin | Exik | Exo-derm | Exoderil | Exolik | Naftifin
  1. Goldstein AO, Goldstein BG. Dermatophyte (tinea) infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 24, 2021.
  2. Gupta AK, Cooper EA. Update in antifungal therapy of dermatophytosis. Mycopathologia. 2008;166(5-6):353-367. doi:10.1007/s11046-008-9109-0 [PubMed 18478357]
  3. Naftifine hydrochloride gel [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals; November 2022.
  4. Naftifine hydrochloride 1% cream [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals; May 2018.
  5. Naftifine hydrochloride 2% cream [prescribing information]. Florham Park, NJ: Xiromed LLC; September 2020.
  6. Naftin 1% cream (naftifine hydrochloride) [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc; April 2018.
  7. Naftin 2% cream (naftifine hydrochloride) [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc; April 2018.
  8. Naftin 1% gel (naftifine hydrochloride) [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc; May 2018.
  9. Naftin 2% gel (naftifine hydrochloride) [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc; April 2020.
  10. Parish LC, Parish JL, Routh HB, et al. A Double-Blind, Randomized, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Naftifine 2% Cream in Tinea cruris. J Drugs Dermatol. 2011a;20(10):1142-1147. [PubMed 21968664]
  11. Parish LC, Parish JL, Routh HB, et al. A Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Naftifine 2% Cream in the Treatment of Tinea pedis. J Drugs Dermatol. 2011b;10(11):1282-1288. [PubMed 22052309]
  12. Patel VM, Schwartz RA, Lambert WC. Topical antiviral and antifungal medications in pregnancy: a review of safety profiles. J Eur Acad Dermatol Venereol. 2017;31(9):1440-1446. doi:10.1111/jdv.14297 [PubMed 28449377]
  13. Refer to manufacturer's labeling.
  14. Stein Gold LF, Parish LC, Vlahovic T, et al. Efficacy and safety of naftifine HCl gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials. J Drugs Dermatol. 2013;12(8):911-918. [PubMed 23986165]
  15. van Zuuren EJ, Fedorowicz Z, El-Gohary M. Evidence-based topical treatments for tinea cruris and tinea corporis: a summary of a Cochrane systematic review. Br J Dermatol. 2015;172(3):616-641. doi:10.1111/bjd.13441 [PubMed 25294700]
  16. Weinstein A, Berman B. Topical treatment of common superficial tinea infections. Am Fam Physician. 2002;65(10):2095-2102. [PubMed 12046779]
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