NDC | 52389-647-09 |
Set ID | 78d792a0-15d5-4c71-a63b-91c24e469df1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Alva-Amco Pharmacal Companies, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- Active Ingredient
- Purpose
- Uses
- Warnings
- ASK DOCTOR
- WHEN USING
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
-
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 over the affected area twice daily (morning and night), or as directed by a doctor.
- This product is not effective on scalp or nails.
- Avoid applying to severely cracked or irritated areas.
- For athlete's foot and ringworm, 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.
- 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 precision QuickBrush applicator. 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
- QUESTIONS
-
Fungicure Maximum Strength Liquid Gel Insert
Maximum Strength FUNGICURE
Manicure & Pedicure Anti-Fungal Treatment
Professional Formula Liquid Gel
- Kills ugly fungus for healthy looking fingers & toes
- Odor free & instant dry
- Liquid Gel locks onto site of infection
The Manicure & Pedicure Fungi Specialist
Maintaining the appearance of your manicure and pedicure requires more than cosmetics. Many manicure procedures can enhance the risk of fungal infection, and certain types of artificial nails can trap moisture and fungi and create a perfect environment for fungus to grow and spread. Cutting cuticles can also create opportunities for fungal infections. When you promptly treat fungal infections on cuticles and nearby skin surfaces, you reduce the risk of the infections spreading.
Fungicure Manicure & Pedicure Liquid Gel is a maximum strength anti-fungal, specifically formulated for those with professionally or home-manicured, pedicured or artificial nails. Fungicure's precision QuickBrush applicator allows for easy application on hard to reach infections, including under nail tips.
WHAT IS FUNGUS INFECTION OF THE FINGER AND TOES?
Common topical fungus infections of the finger and toes are caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which thrive in dark, moist conditions. Using small breaches in the skin's surface, these organisms can cause infection by contact with infected surfaces, animals or people. Once infection starts, spreading may occur. For example, infected fingers and toes may infect other fingers and toes. Although such infections often develop slowly, they may be difficult to eliminate if not treated promptly with an effective anti-fungal medicine like Fungicure.
HOW DO YOU KNOW IF YOU HAVE A TOPICAL FUNGUS INFECTION?
Some topical fungal infections may present themselves on the skin surface as ring-like formations with clear centers; this is commonly called ringworm. Athlete's foot fungus, when in the finger and toe areas, is often characterized by scaling of skin, burning, cracking, itching, and related discomforts. When nails become infected, they may appear to become opaque (cloudy white), thickened, brittle, easily broken, and in some cases, discolored (greenish/brown).
UNDERSTANDING AND TREATING A NAIL AREA INFECTION:
Fungal infections of the nail areas are often caused by the same fungi that lead to athlete's foot and ringworm infections elsewhere on the body. These fungi can infect the entire area around the nails including the cuticles, the nail beds, and even the nails themselves. When infected finger/toe nails are intact, over-the-counter topical anti-fungal treatments may not be able to penetrate the nail and kill the fungus; this is why all OTC topical treatments must indicate they are not effective on the nails. However, in instances of advanced infection, the nails often are not intact; they may be missing, cracked open, or lifted away, exposing the infected nail bed. In these instances FUNGICURE Manicure & Pedicure Liquid Gel, with its powerful anti-fungal formula, can reach and kill nail bed fungus by direct application or related capillary action. Fungicure cures the infection, allowing the natural regrowth of healthy looking tissue.
NOTE: Fungal infections which are isolated beneath an intact nail or embedded within the nail itself may require consultation from a doctor for proper treatment.
HOW FUNGICURE LIQUID GEL WORKS:
MAXIMUM STRENGTH FUNGICURE Manicure & Pedicure Liquid Gel contains Clotrimazole, a widely recognized anti-fungal ingredient that has been proven to be effective against 6 types of fungi such as E. floccosum, T. mentagrophytes, M. canis, M. gypseum, T. tonsurans and T. rubrum.
When applied as directed, FUNGICURE Manicure & Pedicure Liquid Gel acts promptly to target, destroy, and prevent the spread of infection by inhibiting the growth and reproduction of fungal cells.
PROMPT ACTION AND PROPER TREATMENT:
Early treatment of fungal infections is important. If you suspect that you may have a fungal infection, consult your doctor promptly for advice and proper diagnosis. You may wish to show him/her FUNGICURE Manicure & Pedicure Liquid Gel and discuss its use. For best results, once treatment is started with FUNGICURE Manicure & Pedicure Liquid Gel, it is important to carefully follow the treatment instructions on the package until satisfactory results are achieved or advised further by a doctor.
NOTE: Noticeable improvement may be expected within 4 weeks in the case of most ringworm (tinea corporis) and athlete's foot (tinea pedis). Consult your doctor for advice if noticeable improvement is not evident by this time or if condition persists or worsens.
Active Ingredient: Clotrimazole 1% w/w
Uses: For the cure of most:
- ringworm (tinea corporis)
- athlete's foot (tinea pedis).
For relief of:
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomforts which may accompany these conditions.
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.
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 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 severely 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.
- 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 precision QuickBrush applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces.
- While not all finger and toe area 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: Hydroxypropylcellulose and Isopropyl alcohol.
Questions? 1-800-792-2582
www.Fungicure.com
The active ingredient in Fungicure has been recognized to be safe and effective by an FDA Expert Advisory Panel, when used as directed.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FUNGICURE MANICURE PEDICURE LIQUID GEL
clotrimazole gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-647 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 g Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-647-09 1 in 1 BOX 07/06/2016 1 9 g 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 07/05/2016 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)