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NDC 00295-9032-11 Fungi Nail Toe and Foot Anti-Fungal 250 mg/mL Details
Fungi Nail Toe and Foot Anti-Fungal 250 mg/mL
Fungi Nail Toe and Foot Anti-Fungal is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Denison Pharmaceuticals, LLC.. The primary component is UNDECYLENIC ACID.
Product Information
NDC | 00295-9032 |
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Product ID | 0295-9032_8140da3a-a17a-0299-e053-2a91aa0a1454 |
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 | Fungi Nail Toe and Foot Anti-Fungal |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Undecylenic acid |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | TOPICAL |
Active Ingredient Strength | 250 |
Active Ingredient Units | mg/mL |
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 00295-9032-11 (00295903211)
NDC Package Code | 0295-9032-11 |
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Billing NDC | 00295903211 |
Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (0295-9032-11) / 1.7 mL in 1 TUBE, WITH APPLICATOR |
Marketing Start Date | 2019-02-06 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8140da3a-a179-0299-e053-2a91aa0a1454 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions ■ Clean affected areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail ® Toe & Foot ® Anti-fungal Solution over affected area twice daily (morning and night) or as directed by a doctor. ■ The brush applicator allows for easy application under nails and surrounding cuticle area. ■ Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. ■ For athlete’s foot pay special attention to spaces between the toes. ■ For athlete’s foot and ringworm, use daily for 4 weeks. ■ This product is not effective on the scalp or nails. ■ Supervise children in the use of this product.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
FUNGI NAIL TOE AND FOOT ANTI-FUNGAL
undecylenic acid solution |
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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(0295-9032) |