HomeNDC LookupIngredientsNaftifine Hydrochloride › 51672-1368-02
Naftifine Hydrochloride 20 mg/g Cream — NDC 51672-1368-02 package photo

Naftifine Hydrochloride 20 mg/g Cream

by Sun Pharmaceutical Industries, Inc. · 1 TUBE in 1 CARTON (51672-1368-2) / 30 g in 1 TUBE
NDC 51672-1368-02
🏷️ FDA NDC (as labeled) 51672-1368-2 billing pads the package segment with a zero
This package
Contains30 g in 1 tube Pack sizes3 compare ↓
Also priced by: Part D plans $3.53/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 51672-1368-2
Product NDC 51672-1368
11-digit billing NDC 51672136802
RxCUI 1246096
UNII 25UR9N9041
Application # ANDA206901
SPL Set ID a740fc0d-45b3-411f-9dfd-f3d637b8a95f
Established class (EPC) Allylamine Antifungal
Chemical class Allylamine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-01-06
Route TOPICAL
Dosage form CREAM
Substance NAFTIFINE HYDROCHLORIDE
GPI-14 90150078003720
GPI class Naftifine HCl
GCN Seq No 068626
GCN 31452
HICL code 003204
Ingredient (HICL) Naftifine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.04
AHFS class Allylamines (Skin And Mucous Membrane)
FDB label name NAFTIFINE HCL 2% CREAM
FDB brand name Naftifine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 51672-1368-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51672-1368-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Allylamine Antifungal class.

Pharmacologic class Allylamine Antifungal
Drug family (ATC) Other antifungals for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA206901 (ANDA)
Labeler code51672
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio889 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NAFTIFINE HCL 2% CREAM Ingredient Naftifine Hcl
📖 What it is MedlinePlus · NLM

Naftifine is used for skin infections such as athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Naftifine is an antifungal medicine applied to the skin to treat common fungal infections. The gel form (2%) is specifically approved for athlete's foot between the toes — that itc...
  • What exactly is naftifine used to treat?
  • Apply a thin layer once a day to the infected area plus a small border — about a half-inch — of the healthy skin around it. Treatment generally lasts 2 weeks. It's important to fin...
  • How do I apply it, and how long do I need to use it?
📖 Read our full Naftifine Topical guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII D072FFP9GU
    Cetyl esters wax is a waxy substance made from natural or synthetic fatty acids. It's used as a binder, hardening agent, and coating material to give tablets and capsules their structure and texture.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3.53 $106.03 / 30 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naftifine Hydrochloride 20 mg/g 51672-1376-03 Sun 1 tube $8.565 AB Availability likely
Naftifine Hydrochloride 20 mg/gthis 51672-1368-02 Sun 1 tube AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube51672-1368-03 802 Rx · $125,823
1 tube51672-1368-06 270 Rx · $29,915
Drug total (last 4 qtrs): 1,072 Rx · 65,850 units · $155,738 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
51672-1368-02 You're viewing this 1 TUBE in 1 CARTON (51672-1368-2) / 30 g in 1 TUBE 2016-01-06 Active
51672-1368-03 1 TUBE in 1 CARTON (51672-1368-3) / 60 g in 1 TUBE $2.26 / g $135.40 2016-01-06 Active
51672-1368-06 1 TUBE in 1 CARTON (51672-1368-6) / 45 g in 1 TUBE $1.89 / g $84.99 2016-01-06 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-1368-02?
NDC 51672-1368-02 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of Naftifine Hydrochloride 20 mg/g Cream?
Bill NDC 51672-1368-02 — the 11-digit billing format is 51672136802. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51672-1368-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51672-1368-02, written without dashes as 51672136802. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51672-1368-02, the first segment (51672) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (1368) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (51672-1368-03), 1 tube (51672-1368-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 55 words

1 INDICATIONS AND USAGE Naftifine Hydrochloride Cream is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum . Naftifine Hydrochloride Cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum .

⏱️ Dosage and Administration 90 words

2 DOSAGE AND ADMINISTRATION For topical use only. Naftifine Hydrochloride Cream is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of Naftifine Hydrochloride Cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks.

For topical use only. Naftifine Hydrochloride Cream is not for ophthalmic, oral, or intravaginal use. ( 2 ) Apply a thin layer of Naftifine Hydrochloride Cream once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks.

( 2 )

💊 Dosage Forms and Strengths 26 words

3 DOSAGE FORMS AND STRENGTHS Each gram of Naftifine Hydrochloride Cream contains 20 mg of naftifine hydrochloride (2%) in a white to off-white base. Cream: 2%

Contraindications 4 words

4 CONTRAINDICATIONS None None

⚠️ Warnings and Cautions 53 words

5 WARNINGS AND PRECAUTIONS Discontinue treatment if redness or irritation develops with Naftifine Hydrochloride Cream use. ( 5.1 )

5.1Local Adverse Reactions Discontinue treatment if irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream. Direct patients to contact their physician if these conditions develop following use of Naftifine Hydrochloride Cream.

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The most common adverse reaction (≥1%) is pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During clinical trials, 903 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 564 subjects with interdigital tinea pedis, tinea cruris, or tinea corporis were treated with Naftifine Hydrochloride Cream.

In two randomized, vehicle-controlled trials (400 subjects were treated with Naftifine Hydrochloride Cream). The population was 12 to 88 years old, primarily male (79%), 48% Caucasian, 36% Black or African American, 40% Hispanic or Latino and had either predominantly interdigital tinea pedis or tinea cruris. Most subjects received doses once-daily, topically, for 2 weeks to cover the affected skin areas plus a ½ inch margin of surrounding healthy skin.

In the two vehicle-controlled trials, 17.5% of Naftifine Hydrochloride Cream treated subjects experienced an adverse reaction compared with 19.3% of vehicle subjects. The most common adverse reaction (≥1%) is pruritus. Most adverse reactions were mild in severity.

The incidence of adverse reactions in the Naftifine Hydrochloride Cream treated population was not significantly different than in the vehicle treated population. In a third randomized, vehicle-controlled trial, 116 pediatric subjects with tinea corporis were treated with Naftifine Hydrochloride Cream. The population was aged ≥2 to <18 years (mean age of 9 years), predominately male (61%), 47% White, 51% Black or African American, 92% Hispanic or Latino, and infected with tinea corporis.

Naftifine Hydrochloride Cream was topically applied once daily for 2 weeks to all affected body surface areas with tinea corporis plus a ½ inch margin of healthy skin surrounding the affected lesions. The incidence of adverse reactions in the Naftifine Hydrochloride Cream treated population was not significantly different than in the vehicle treated population. In two open-label pediatric pharmacokinetics and safety trials, 49 pediatric subjects 2 to <18 years of age with interdigital tinea pedis, tinea cruris, and tinea corporis received Naftifine Hydrochloride Cream.

The incidence of adverse reactions in the pediatric population was similar to that observed in the adult population.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of naftifine hydrochloride: redness/irritation, inflammation, maceration, swelling, burning, blisters, serous drainage, crusting, headache, dizziness, leukopenia, agranulocytosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data with Naftifine Hydrochloride Cream in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 18 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 2 times the MRHD in pregnant rats or 4 times the MRHD in pregnant rabbits [see Data ] .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. For the comparison of animal to human doses based on body surface area comparison (mg/m 2 ), the MRHD is set at 8 g 2% cream per day (2.67 mg/kg/day for a 60 kg individual). Oral doses of 30 mg/kg/day, 100 mg/kg/day and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats.

No treatment-related effects on embryofetal development were noted at doses up to 300 mg/kg/day (18 times MRHD). Subcutaneous doses of 10 mg/kg/day and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. No treatment-related effects on embryofetal development were noted at 30 mg/kg/day (2 times MRHD).

Subcutaneous doses of 3 mg/kg/day, 10 mg/kg/day and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rabbits. No treatment-related effects on embryofetal development were noted at 30 mg/kg/day (4 times MRHD). A peri- and post-natal development study was conducted in rats.

Oral doses of 30 mg/kg/day, 100 mg/kg/day and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. Reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (18 times MRHD). No developmental toxicity was noted at 100 mg/kg/day (6 times MRHD).

8.2Lactation Risk Summary There is no information available on the presence of Naftifine Hydrochloride Cream in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Naftifine Hydrochloride Cream to an infant during lactation; therefore, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Naftifine Hydrochloride Cream and any potential adverse effects on the breastfed infant from Naftifine Hydrochloride Cream or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Naftifine Hydrochloride Cream have been established in pediatric patients age 12 and above with interdigital tinea pedis and tinea cruris and age 2 and above with tinea corporis [see Clinical Studies (14) and Clinical Pharmacology (12.3) ] . Use of Naftifine Hydrochloride Cream in these age groups is supported by evidence from adequate and well controlled studies in adults and children, with additional safety and PK data from two open label trials conducted in 49 pediatric subjects exposed to Naftifine Hydrochloride Cream [see Clinical Studies (14) and Clinical Pharmacology (12.3) ] .

Safety and effectiveness of Naftifine Hydrochloride Cream in the treatment of tinea cruris and interdigital tinea pedis in pediatric patients less than 12 years of age have not been established. Safety and effectiveness…

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are no available data with Naftifine Hydrochloride Cream in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 18 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 2 times the MRHD in pregnant rats or 4 times the MRHD in pregnant rabbits [see Data ] .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. For the comparison of animal to human doses based on body surface area comparison (mg/m 2 ), the MRHD is set at 8 g 2% cream per day (2.67 mg/kg/day for a 60 kg individual). Oral doses of 30 mg/kg/day, 100 mg/kg/day and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats.

No treatment-related effects on embryofetal development were noted at doses up to 300 mg/kg/day (18 times MRHD). Subcutaneous doses of 10 mg/kg/day and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. No treatment-related effects on embryofetal development were noted at 30 mg/kg/day (2 times MRHD).

Subcutaneous doses of 3 mg/kg/day, 10 mg/kg/day and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rabbits. No treatment-related effects on embryofetal development were noted at 30 mg/kg/day (4 times MRHD). A peri- and post-natal development study was conducted in rats.

Oral doses of 30 mg/kg/day, 100 mg/kg/day and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. Reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (18 times MRHD). No developmental toxicity was noted at 100 mg/kg/day (6 times MRHD).

🧒 Pediatric Use 156 words

8.4Pediatric Use The safety and effectiveness of Naftifine Hydrochloride Cream have been established in pediatric patients age 12 and above with interdigital tinea pedis and tinea cruris and age 2 and above with tinea corporis [see Clinical Studies (14) and Clinical Pharmacology (12.3) ] . Use of Naftifine Hydrochloride Cream in these age groups is supported by evidence from adequate and well controlled studies in adults and children, with additional safety and PK data from two open label trials conducted in 49 pediatric subjects exposed to Naftifine Hydrochloride Cream [see Clinical Studies (14) and Clinical Pharmacology (12.3) ] .

Safety and effectiveness of Naftifine Hydrochloride Cream in the treatment of tinea cruris and interdigital tinea pedis in pediatric patients less than 12 years of age have not been established. Safety and effectiveness of Naftifine Hydrochloride Cream in the treatment of tinea corporis in pediatric patients less than 2 years of age have not been established.

🧓 Geriatric Use 29 words

8.5Geriatric Use Clinical studies of Naftifine Hydrochloride Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~3 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Naftifine Hydrochloride Cream is a topical antifungal drug [see Clinical Pharmacology (12.4) ]

12.2Pharmacodynamics The pharmacodynamics of Naftifine Hydrochloride Cream have not been established.

12.3Pharmacokinetics In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. The pharmacokinetics of Naftifine Hydrochloride Cream was evaluated following once-daily topical application for 2 weeks to 21 adult subjects, both males and females, with both tinea pedis and tinea cruris. The median total amount of cream applied was 6.4 g (range 5.3 to 7.5 g) per day.

The results showed that the systemic exposure (i.e., maximum concentration (C max ) and area under the curve from time 0 to 24 hours (AUC 0-24 )) to naftifine increased over the 2 week treatment period in all the 21 subjects. Geometric mean (coefficient of variation or CV%) AUC 0-24 was 117 (41.2) ng*hr/mL on Day 1, and 204 (28.5) ng*hr/mL on Day 14. Geometric mean (CV%) C max was 7 ng/mL (55.6) on Day 1 and 11 ng/mL (29.3) on Day 14.

Median time to C max (T max ) was 8 hours (range: 4 to 24 hours) on Day 1 and 6 hours (range: 0 to 16 hours) on Day 14. Accumulation after 14 days of topical application was less than two fold. Trough concentrations generally increased throughout the 14 day study period.

Naftifine continued to be detected in plasma in 13/21 (62%) subjects on Day 28, the mean (standard deviation or SD) plasma concentrations were 1.6 ± 0.5 ng/mL (range below limit of quantitation (BLQ) to 3 ng/mL). In the same pharmacokinetic trial conducted in patients with tinea pedis and tinea cruris, median fraction of the dose excreted in urine during the treatment period was 0.0016% on Day 1 versus 0.0020% on Day 14. In a second trial that enrolled 22 subjects, the pharmacokinetics of Naftifine Hydrochloride Cream was evaluated in 20 pediatric subjects 13 to <18 years of age with both tinea pedis and tinea cruris.

Subjects were treated with a median dose of 8.1 g (range 6.6 to 10.1 g) applied to the affected areas once daily for 2 weeks. The results showed that the systemic exposure increased over the treatment period. Geometric mean (CV%) AUC 0-24 was 138 (50.2) ng*hr/mL on Day 1, and 192 (74.9) ng*hr/mL on Day 14.

Geometric mean (CV%) C max was 9.21 ng/mL (48.4) on Day 1 and 12.7 ng/mL (67.2) on Day 14. Median fraction of the dose excreted in urine during the treatment period was 0.0030% on Day 1 and 0.0033% on Day 14. A third trial evaluated the pharmacokinetics of Naftifine Hydrochloride Cream in 27 pediatric subjects 2 to < 12 years of age with at least moderate tinea corporis.

Subjects were divided into younger (ages 2 to < 6 years, 17 subjects) and older (6 to <12 years, 10 subjects) groups. Median doses of 1.3 g (range 1 to 3.1 g) and 2.3 g (range 2.2 to 4.2 g) were applied once-daily for 2 weeks in the younger and older groups, respectively, to the affected area plus a ½ inch margin. Plasma and urine pharmacokinetic assessments were conducted on Day 1 in the older group only and on Day 14 in both groups.

All subjects showed measurable levels of naftifine in plasma after topical application of Naftifine Hydrochloride Cream. Following a single dose on Day 1 in subjects 6 to < 12 years of age, the geometric mean (CV%) values of C max and AUC 0-24 were 3.60 (76.6) ng/mL and 49.8 (64.4) ng*h/mL, respectively. On Day 14 in this group, the C max and AUC 0-24 were 3.31 (51.2) ng/mL and 52.4 (49.2) ng*h/mL, respectively.

In subjects 2 to < 6 years of age on Day 14, the C max and AUC 0-24 were 3.98 (186) ng/mL and 54.8 (150) ng*h/mL, respectively. In the older group of subjects 6 to 12 years of age, the systemic exposures (both C max and AUC 0-24 ) on Days 1 and 14 were comparable. The median fraction of the dose excreted into urine over 24 hours following drug applications on Day 1 and Day 14 was 0.0029%…

🧬 Mechanism of Action 17 words

12.1Mechanism of Action Naftifine Hydrochloride Cream is a topical antifungal drug [see Clinical Pharmacology (12.4) ]

📦 How Supplied / Storage and Handling 60 words

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Naftifine Hydrochloride Cream USP, 2% is a white to off-white cream supplied in tubes in the following sizes: 30 g – NDC 51672-1368-2 45 g – NDC 51672-1368-6 60 g – NDC 51672-1368-3 Storage: Store Naftifine Hydrochloride Cream USP, 2% at 20° to 25°C (68 ° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 20 words

Storage: Store Naftifine Hydrochloride Cream USP, 2% at 20° to 25°C (68 ° to 77°F) [see USP Controlled Room Temperature].

📋 Description 93 words

11 DESCRIPTION Naftifine Hydrochloride Cream is a white to off-white cream for topical use only. Each gram of Naftifine Hydrochloride Cream contains 20 mg of naftifine hydrochloride (2%), a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride.

The molecular formula is C 21 H 21 N∙HCl with a molecular weight of 323.86. The structural formula of naftifine hydrochloride is: Naftifine Hydrochloride Cream contains the following inactive ingredients: benzyl alcohol, cetyl alcohol, cetyl esters wax, hydrochloric acid, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Chemical Structure

💬 Information for Patients 65 words

17 PATIENT COUNSELING INFORMATION Inform patients that Naftifine Hydrochloride Cream is for topical use only. Naftifine Hydrochloride Cream is not intended for oral, intravaginal or ophthalmic use. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream treatment should be discontinued and appropriate therapy instituted.

Patients should be directed to contact their physician if these conditions develop following use of Naftifine Hydrochloride Cream.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.