Label: FUNGICURE LIQUID GEL- clotrimazole liquid
- NDC Code(s): 0295-1363-31
- Packager: Denison Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 17, 2019
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
- 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
- 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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
FUNGICURE LIQUID GEL
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)