NDC | 0295-1363-31 |
Set ID | 7fa89075-5501-3441-e053-2991aa0ae0ff |
Category | HUMAN OTC DRUG LABEL |
Packager | Denison Pharmaceuticals, LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- INACTIVE INGREDIENT
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FUNGICURE LIQUID GEL
clotrimazole liquidProduct 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)