Fungi Nail Toe and Foot Pen

Manufacturer
Kramer Laboratories | Denison Pharmaceuticals, LLC
Effective date
2019-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:34:27

Label at a glance#

ProductFungi Nail Toe and Foot Pen
Active ingredientUndecylenic acid
Label structure11 sections

Storage and handling

Other information Store at room temperature 15°-30°C (59°-86°F). Protect from freezing. If freezing occurs warm to room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Undecylenic acid 25%Anti-fungal

INDICATIONS & USAGE SECTION

Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ for effective relief of itching, burning and cracking.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product ■ avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if ■ irritation occurs ■ there is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

DOSAGE & ADMINISTRATION SECTION

Directions ■ Clean affected area with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail® Toe & Foot® Anti-Fungal Solution over affected area twice daily (morning and night) or as directed by a doctor. ■ The brush applicator allows for easy application on skin around the nail and cuticle area. ■ Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ■ For athlete's foot pay special attention to space between the toes. ■ For athlete's foot and ringworm, use daily for 4 weeks. ■  For toe fungus, apply under nail and cuticle area. If condition persists longer, consult a doctor. ■ This product is not effective on the scalp or nails. ■ Supervise children in the use of this product.

STORAGE AND HANDLING SECTION

Other information Store at room temperature 15°-30°C (59°-86°F). Protect from freezing. If freezing occurs warm to room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredient Isopropyl Palmitate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 Pharmacist Recommended

MAXIMUM STRENGTH

FUNGI-NAIL®

ANTI-FUNGAL
PEN


Clinically Proven to Cure Fungal Infections


MAXIMUM STRENGTH

FUNGI-NAIL
TRIPLE ACTION FORMULA
✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health

.101 FL OZ (3ml)

Instructions for Use:
Twist base with brush pointing downward to saturate brush (Figure1). If you do not hear a click, turn the other way. First time use may require several twists to initiate product flow. Please note product is clear: apply brush to skin to confirm proper dispersion of solution.

FUNGI-NAIL ANTI-FUNGAL PEN is the No-Mess, No-Spill, targeted treatment pen applicator that delivers the right amount of treatment right where you need it.

Fungi-Nail Is Specially Formulated:

Clear water-resistant barrier locks medicine in.

Kills fungus and restores skin.

For best results treat around all toenails and in between toes.

Not for nail or scalp fungus.

Cures most athlete's foot.

CLINICALLY PROVEN MEDICINE

Convenient and easy to Apply Pen Applicator

Deep Penetrating Medicine that Stays in Place

Restores Skin Health

K1018

DO NOT USE IF NECKBAND IS BROKEN OR MISSING

For more information about Fungi-Nail and money back guarantee, visit us at funginail.com

KRAMER
LABORATORIES


Kramer Laboratories, Inc.
Coral Gables, FL 33134

kramerlabs.com
funginail.com

1-800-824-4894

carton
carton

25% UNDECYLENIC ACID

NDC#: 55505-187-51

THE ORIGINAL
FUNGI-NAIL®
TOE & FOOT® BRAND

ANTI-FUNGAL SOLUTION PEN

0.101 FL OZ (3mL)

Directions: Clean affected area with soap and water. Dry thoroughly. Twist pen base to saturate brush, then only as needed. Do not over twist. Apply around cuticle and underneath the edge of the nail twice daily.

Keep carton for complete information.

K0317

KRAMER LAORATORIES

kramerlabs.com
fungi-nail.com
1-800-824-4894

TWIST TOP TO BREAK SEAL OR PEEL HERE

SEALED FOR YOUR PROTECTION

FOR EXTERNAL USE ONLY.

DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN, TORN OR MISSING.
 

label
label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-187-51ML - Milliliter55505-187678a1b57-635e-452b-8b6e-bffb7d04b0e212017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Undecylenic acidACTIVE INGREDIENTK3D86KJ24N2
Undecylenic acidACTIVE MOIETYK3D86KJ24N2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-18755505-187-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Undecylenic acidK3D86KJ24NACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM / TRANSDERMAL2 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM, EXTENDED RELEASE / TRANSDERMAL187.5 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9e220f83-60d1-4368-bb3f-4b975affc3a9bc737ee2-0651-4f02-8157-bbed81507c352019-01-08WarningsExact identifier
spl set id: bc737ee2-0651-4f02-8157-bbed81507c35

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.