FUNGICURE MANICURE PEDICURE ANTI FUNGAL- clotrimazole liquid

Fungicure Manicure Pedicure Anti Fungal by

Drug Labeling and Warnings

Fungicure Manicure Pedicure 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

Clotrimazole 1% w/v.

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

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 Manicure & Pedicure Liquid 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 athlete's foot: pay special attentino to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
• For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
• 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 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 MANICURE PEDICURE ANTI FUNGAL 
clotrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-6307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-6307-05	30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/12/2018
2	NDC: 0295-6307-44	60 mL in 1 BOTTLE, 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(0295-6307)