MedPath

Bee Venom Toenail Fungus Treatment

Approved
Approval ID

3e7d22b0-2f57-fcac-e063-6394a90aefd9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 10, 2025

Manufacturers
FDA

Shenzhen Earth Surface Trading Co., Ltd.

DUNS: 454290055

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bee Venom Toenail Fungus Treatment

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85636-008
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bee Venom Toenail Fungus Treatment
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 10, 2025
FDA Product Classification

INGREDIENTS (9)

APIS MELLIFERA VENOMInactive
Code: 76013O881M
Classification: IACT
GARLICInactive
Code: V1V998DC17
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
ANGELICA ACUTILOBA ROOTInactive
Code: 3W51R3EK30
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
UNDECYLENIC ACIDActive
Quantity: 250 mg in 1 mL
Code: K3D86KJ24N
Classification: ACTIB
LONICERA JAPONICA FLOWERInactive
Quantity: 1000 mg in 1 mL
Code: 4465L2WS4Y
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/15/2024

Uses

Effective in getting rid of fungus and promoting healthier nail growth.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/15/2024

inactive ingredients

Water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredients

Undecylenic Acid 25% W/W

Bee Venom 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/15/2025

PURPOSE

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 10/15/2024

Warnings

• For external use only.
• When using this product avoid contact with eyes. If contact occurs,
rinse thoroughly with water.
• Stop use and ask/ consult a doctor/ physician/ health care
practitioner/ health care provider/ health care professional if irritation
or symptoms worsen or last for more than 4 weeks.
• Keep out of reach of children. If swallowed, call a poison control
centre or get medical help right away、

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 10/15/2024

Stop use and ask a doctor if

if irritation or symptoms worsen
or last for more than 4 weeks.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 10/15/2024

Do not use

• If you are pregnant or breastfeeding
• your skin is injured or cracked.
• you are under 12 years of age.
• irritation or discomfort occurs.
• you are using other medicines on your nails.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 10/15/2024

When using this product

• Do not apply to other parts of the body.
• Avoid making eye contact. In case of accidental eye contact, flush
eyes with copious amounts of cold tap water.
• This product may not work for everyone.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/15/2024

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/15/2024

Directions

Soak the affected nail inwarm water
to soften it. Gently file the nail to
thin it and remove dirt, being cau-
tious not to harm the nail bed.
Application: Apply full layers of
the solution with the brush onto
affected areas on, around, and
under the nails.a light tingle or burn
is normal for the first 10 minutes
until absorbed.
Frequency: Use twice daily
(morningand night). Visible results
may appear in 6 weeks. Continue
regular use to prevent regrowth.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 10/15/2024

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Bee Venom Toenail Fungus Treatment - FDA Drug Approval Details