FUNGICURE LIQUID GEL- clotrimazole liquid

Fungicure Liquid Gel by

Drug Labeling and Warnings

Fungicure Liquid Gel 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

Clotrimazole 1% w/w.

PURPOSE

Purpose

Antifungal

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses

For the cure of most:

• ringworm (tinea corpis)
• athlete's foot (tinea pedis)

For relief of:

• itching
• scaling
• cracking
• burning
• redness
• soreness
• irritation
• discomforts which may accompany these conditions

WARNINGS

Warnings

For external use only.

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

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

INACTIVE INGREDIENT

Inactive ingredient

Hydroxypropylcellulose and Isopropyl alcohol

DOSAGE & ADMINISTRATION

Directions

• Read and all package directions and warnings before using.
• Use only as directed.
• Clean the affected area with soap with warm water and dry thoroughly.
• Apply a thin layer of FUNGICURE over the affected area twice daily (morning and night), or as directed by a doctor.
• This product is not effective on the scalp or nails.
• Avoid applying to severly cracked or irritated areas.
• For ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
• 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.
• Intented 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 SAFETY INFORMATION

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

QUESTIONS

Questions? 1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGICURE LIQUID GEL 
clotrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1363
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1363-31	10.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	12/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/12/2018

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-1363)