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NDC 00295-9810-10 Fungicure Anti-Fungal Liquid 25% 250 mg/g Details
Fungicure Anti-Fungal Liquid 25% 250 mg/g
Fungicure Anti-Fungal Liquid 25% is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Denison Pharmaceuticals LLC. The primary component is UNDECYLENIC ACID.
Product Information
NDC | 00295-9810 |
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Product ID | 0295-9810_81dc6d51-968a-5093-e053-2991aa0a426f |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Fungicure Anti-Fungal Liquid 25% |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Undecylenic Acid |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | TOPICAL |
Active Ingredient Strength | 250 |
Active Ingredient Units | mg/g |
Substance Name | UNDECYLENIC ACID |
Labeler Name | Denison Pharmaceuticals LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part333C |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 00295-9810-10 (00295981010)
NDC Package Code | 0295-9810-10 |
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Billing NDC | 00295981010 |
Package | 38 g in 1 TUBE, WITH APPLICATOR (0295-9810-10) |
Marketing Start Date | 2019-02-20 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 81dc6d51-968b-5093-e053-2991aa0a426f Details
Uses
SPL UNCLASSIFIED SECTION
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.
INGREDIENTS AND APPEARANCE
FUNGICURE ANTI-FUNGAL LIQUID 25%
undecylenic acid liquid |
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Labeler - Denison Pharmaceuticals LLC (001207208) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Denison Pharmaceuticals LLC | 001207208 | manufacture(0295-9810) |