NDC | 0295-9032-05, 0295-9032-11, 0295-9032-16 |
Set ID | 8140da3a-a179-0299-e053-2a91aa0a1454 |
Category | HUMAN OTC DRUG LABEL |
Packager | Denison Pharmaceuticals, LLC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FUNGI NAIL TOE AND FOOT ANTI-FUNGAL
undecylenic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-9032 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 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-9032-05 1 in 1 CARTON 02/06/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0295-9032-16 1 in 1 CARTON 02/06/2019 2 3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 3 NDC:0295-9032-11 1 in 1 CARTON 02/06/2019 3 1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/06/2019 Labeler - Denison Pharmaceuticals, LLC. (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC. 001207208 manufacture(0295-9032)