Bldaxn FUNGAL NAIL RENEWAL by Jiangxi Hemei Pharmaceutical Co., Ltd 84010-135 complete

Bldaxn FUNGAL NAIL RENEWAL by

Drug Labeling and Warnings

Bldaxn FUNGAL NAIL RENEWAL by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLDAXN FUNGAL NAIL RENEWAL- undecylenic acid 25% fungal nail renewal liquid 
Jiangxi Hemei Pharmaceutical Co., Ltd

----------

84010-135 complete

Active Ingredient

Undecylenic Acid 25%

Purpose

Anti-Fungal

Use

Hinder fungal growth.

Warnings

For external use only.

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.

When Using

When using this product Avoid contact with eyes.

Stop Use

Stop use and ask a doctor If discomfort persists.

Ask Doctor

If you have diabetes or poor blood circulation.

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.

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)

Other information

·Store at room temperature 15-30°C(59-86°F)

Inactive ingredients

Water, Euphorbia hirta whole, Glycerin, Lavender Oil, Peppermint Oil, Jojoba Oil, Tea Tree Oil, Almond Oil, Manuka Oil

PRINCIPAL DISPLAY PANEL

BLDAXN FUNGAL NAIL RENEWAL 
undecylenic acid 25% fungal nail renewal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-135
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)
MANUKA OIL (UNII: M6QU9ZUH2X)
PEPPERMINT OIL (UNII: AV092KU4JH)
EUPHORBIA HIRTA WHOLE (UNII: L13YF113GN)
TEA TREE OIL (UNII: VIF565UC2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-135-01	2 in 1 BOX	06/19/2025
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/19/2025	02/08/2026

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-135)

Revised: 2/2026

Document Id: 4a4c14eb-5604-9c96-e063-6394a90a90b2

34390-5

Set id: 37e8c837-4e5d-d380-e063-6294a90a6aad

Version: 2

Effective Time: 20260208