NDC | 0295-9810-05, 0295-9810-10 |
Set ID | 81dc6d51-968b-5093-e053-2991aa0a426f |
Category | HUMAN OTC DRUG LABEL |
Packager | Denison Pharmaceuticals LLC |
Generic Name | |
Product Class | |
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 Liquid over the affected area twice daily (morning and night), or as directed by a doctor.
This product is not effective on scalp or nails.
For ringworm and athlete's foot, use daily for 4 weeks.
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.
If condition persists longer, consult a doctor.
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 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.
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FUNGICURE ANTI-FUNGAL LIQUID 25%
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-9810 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 250 mg in 1 g Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-9810-05 28 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 02/20/2019 2 NDC:0295-9810-10 38 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 02/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/20/2019 Labeler - Denison Pharmaceuticals LLC (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals LLC 001207208 manufacture(0295-9810)