FUNGI NAIL TOE AND FOOT- undecylenic acid liquid

Fungi Nail Toe and Foot by

Drug Labeling and Warnings

Fungi Nail Toe and Foot by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Dension Pharmecuticals. 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 this product ■ avoid contact with eyes.

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 MEDICATON OUT OF 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 spaces between the toes. ■ For athlete’s foot and ringworm, use daily for 4 weeks. For toe fungus, apply under nail and around 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 controlled 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
LIQUID

Clinically Proven to Cure Fungal Infections

TRIPLE ACTION FORMULA

✓ Kills Fungus
✓ Stops Itching & Burning
✓ Restores Skin Health

CLINICALLY PROVEN MEDICINE

1 FL. OZ (30 ML)

Convenient and Easy to Apply

Deep Penetrating Medicine that Stays in Place

Not actual size.

FUNGI-NAIL® ANTI FUNGAL LIQUID
comes with a pinpoint brush applicator ideal for treating toe and foot fungus.

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

Not for nail or scalp fungus.

Cures most athlete's foot.

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

K1018

Kramer Laboratories, Inc.
Coral Gables, FL 33134
kramerlabs.com
funginail.com
1-800-824-4894

NDC#: 55505-103-26

THE ORIGINAL
FUNGI-NAIL®
TOE & FOOT BRAND

MAXIMUM STRENGTH ANTI-FUNGAL

KILLS FUNGUS
RESTORES SKIN

1 FL. OZ. (30mL)

Distributed By:
KRAMER
LABORATORIES

Kramer Laboratories
Coral Gables, FL 33134 U.S.A.

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

K0318

INGREDIENTS AND APPEARANCE

FUNGI NAIL TOE AND FOOT 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-103
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: 55505-103-26	1 in 1 CARTON	12/07/2010
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 55505-103-27	1 in 1 CARTON	04/01/2018
2		37 mL in 1 BOTTLE, GLASS; 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	12/07/2010

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Dension Pharmecuticals		001207208	manufacture(55505-103)