FUNGI NAIL TOE AND FOOT ANTI-FUNGAL- undecylenic acid solution

Fungi Nail Toe and Foot Anti-Fungal by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient....................Purpose

Undecylenic Acid.....................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.

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 areas 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 under nails and surrounding 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. ■ 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

INGREDIENTS AND APPEARANCE

FUNGI NAIL TOE AND FOOT ANTI-FUNGAL 
undecylenic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9032
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: 0295-9032-05	1 in 1 CARTON	02/06/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0295-9032-16	1 in 1 CARTON	02/06/2019
2		3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
3	NDC: 0295-9032-11	1 in 1 CARTON	02/06/2019
3		1.7 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	02/06/2019

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-9032)