Other
Drug Facts
Myco Nail A Antifungal Solution Liquid
FDA Label NDC 52083-242
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Myco Nail A Antifungal Solution (NDC 52083-242). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Undecylenic Acid 25% v/v
Purpose
Antifungal
Uses
For the treatment of athlete's foot (tinea pedis), ringworm (tinea corporis). For effective relief of itching, irritation, and burning feet.
Warnings
For external use only. Flammable: Keep away from fire and flame.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a physician.
Otc - When Using
When using this product avoid contact with the eyes and mucuos membranes.
Stop use and ask a doctor if irritation occurs or is there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If you are pregnant or breast-feeding consult a health care professional before using this product.
Directions
Clean the affected area and dry thoroughly. Apply a thin layer of Myco Nail A over the affected area twice daily (morning and night) or as directed by a physician. Supervise children in the use of this product. For athlete's foot: pay special attention to spaces between toes; wear well-fitted, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a physcian.
Other Information
Store between 15 - 30 C (50 – 86F).
Do not accept if safety seal is broken or missing.
Inactive Ingredients
Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.
Questions Or Omments:
Kramer Novis, San Juan PR, 1-787-767-2072
Principal Display Panel - 30Ml Bottle Carton
Myco Nail A®
Antifungal Solution
Topical Formula
1 Fl. Oz. 30 ml.
MANUFACTURED IN USA FOR
KRAMER-NOVIS
San Juan, P.R. 00918
Principal Display Panel (30ml Bottle Carton)
* Please review the disclaimer below.
