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

Undecylenic acid 25%

PURPOSE

Antifungal

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.

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

Directions ■ Clean affected are a with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail®Brand 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 under nails and surrounding cuticle area.

INACTIVE INGREDIENT

Isopropyl Palmitate

WARNINGS

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGI NAIL TOE AND FOOT PEN 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-167
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: 55505-167-20	1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	12/05/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/05/2010

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(55505-167)