Bldaxn FUNGAL NAIL RENEWAL
84010-135
37e8c837-4e5d-d380-e063-6294a90a6aad
HUMAN OTC DRUG LABEL
Jun 19, 2025
Jiangxi Hemei Pharmaceutical Co., Ltd
DUNS: 724892056
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Undecylenic Acid 25% FUNGAL NAIL RENEWAL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Use
Hinder fungal growth.
WARNINGS SECTION
Warnings
For external use only.
OTC - DO NOT USE SECTION
Do not use
·On open wounds or severely irritated skin.(Consult a doctor if condition
covers a large area, worsens, or persists for more than 4 weeks.)
·If you are pregnant or experience an allergic reaction to this product.
OTC - WHEN USING SECTION
When Using
When using this product Avoid contact with eyes.
OTC - STOP USE SECTION
Stop Use
Stop use and ask a doctor If discomfort persists.
OTC - ASK DOCTOR SECTION
Ask Doctor
If you have diabetes or poor blood circulation.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out Of Reach Of Children
·If the product gets into your eyes, flush with water for 15 minutes.
·If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
·Wash feet thoroughly with warm water, and gently file the thickened part of
the nail with a nail file until it is flat.
·Apply a layer of the liquid to the surface of the nail and allow it to be
absorbed.Repeat the process twice a day.
·Use it continuously for at least 4 weeks to see an effect.
·For complete improvement, we recommend using it for 6 weeks or more. (Only
for adults and children 12 years and over)
STORAGE AND HANDLING SECTION
Other information
·Store at room temperature 15-30°C(59-86°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
Water, Euphorbia hirta whole, Glycerin, Lavender Oil, Peppermint Oil, Jojoba Oil, Tea Tree Oil, Almond Oil, Manuka Oil
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Undecylenic Acid 25%
OTC - PURPOSE SECTION
Purpose
Anti-Fungal