FUNGICURE ANTI-FUNGAL LIQUID 25%- undecylenic acid liquid

Fungicure Anti-Fungal Liquid 25% by

Drug Labeling and Warnings

Fungicure Anti-Fungal Liquid 25% by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Undecylenic acid 25% w/w

Purpose

Antifungal

Uses

For the cure of most

• ringworm (tinea corporitis) and athlete's foot (tinea pedis).

For relief of itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts which may accompany these conditions.

Warnings

For external use only.

ASK DOCTOR

Ask a doctor before use on children under 2 years of age.

WHEN USING

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

• Irritation occurs
• There is no improvement within 4 weeks.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

Directions

Read all package directions and warnings before use.
Use only as directed.
Clean the affected area with soap and warm water and dry thoroughly.
Apply a thin layer of FUNGICURE Liquid over the affected area twice daily (morning and night), or as directed by a doctor.
This product is not effective on scalp or nails.
For ringworm and athlete's foot, use daily for 4 weeks.
For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
If condition persists longer, consult a doctor.
Intended for use by normally healthy adults only.
Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
Supervise children in the use of this product.

Other information

• FUNGICURE may be applied to exposed nail beds, cuticles, around nail edges and under nail tips where reachable with its applicator brush.
• This product is not intended to, nor will it, penetrate hard nail surfaces.
• While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained.
• You may report serious side effects to the phone number provided under Questions? below.
  

Inactive ingredients

Isopropyl palmitate

QUESTIONS

Questions? 1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGICURE ANTI-FUNGAL LIQUID 25% 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9810
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 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9810-05	28 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	02/20/2019
2	NDC: 0295-9810-10	38 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	02/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/20/2019

Labeler - Denison Pharmaceuticals LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals LLC		001207208	manufacture(0295-9810)