FUNGI NAIL TOE AND FOOT PEN- undecylenic acid liquid

Fungi Nail Toe and Foot Pen by

Drug Labeling and Warnings

Fungi Nail Toe and Foot Pen by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredient: Purpose
• Undecylenic acid 25%: Anti-fungal

INDICATIONS & USAGE

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

For external use only

DO NOT USE

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

WHEN USING

When using this product ■ avoid contact with eyes.

INDICATIONS & USAGE

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

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

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

INACTIVE INGREDIENT

Inactive ingredient Isopropyl Palmitate

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

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.
 

INGREDIENTS AND APPEARANCE

FUNGI NAIL TOE AND FOOT PEN 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N)	Undecylenic acid	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-187-51	1 in 1 CARTON	04/17/2015
1		3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/17/2015

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(55505-187)