NDC | 0295-9008-16 |
Set ID | 7ee60b49-f12f-a0e1-e053-2991aa0a356e |
Category | HUMAN OTC DRUG LABEL |
Packager | Denison Pharmaceuticals, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- read all warnings and directions
- use only as directed
- clean the affected area with soap and water and dry thoroughly
- remove cap from pen, with brush pointing downward, until product dispenses
- apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
- for athlete's foot, pay special attention to spaces between the toes; well-fitting, ventilated shoes, and change shoes and socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
- supervise children in the use of this product
- this product is not effective on the scalp or nails
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CVS MAXIMUM STRENGTH ANTI-FUNGAL PEN 25%
undecylenic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0295-9008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 25 mg in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0295-9008-16 3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/09/2019 Labeler - Denison Pharmaceuticals, LLC (001207208) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 manufacture(0295-9008)