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Reaua BEE VENOM TAG WART REMOVER

84010-173

Approved
Approval ID

3d506aba-c4f3-c6a9-e063-6394a90a28af

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

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.

Salicylic acid 16% Bee Venom 1% BEE VENOM TAG WART REMOVER

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-173
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic acid 16% Bee Venom 1% BEE VENOM TAG WART REMOVER
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (6)

BORNEOLInactive
Code: M89NIB437X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
APIS MELLIFERA VENOMActive
Quantity: 1 g in 100 mL
Code: 76013O881M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SALICYLIC ACIDActive
Quantity: 16 g in 100 mL
Code: O414PZ4LPZ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/27/2025

PRINCIPAL DISPLAY PANEL

16

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2025

Use

For the removal of common warts and plantar warts.Common warts have a rough"cauliflower-like" surface and are easily recognizable.Plantar warts are located only on the soles of the feet, tender to touch, with an interrupted footprint pattern.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/27/2025

Active Ingredient

Salicylic acid 16% Bee Venom 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/27/2025

Purpose

Wart remover

WARNINGS SECTION

LOINC: 34071-1Updated: 8/27/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/27/2025

Do not use

on irritated skin or on any area that is infected or reddened.On moles, birthmarks,warts with hair growing from them, genital warts, or warts on the face or mucous membranes.lf you have diabetes or poor blood circulation.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/27/2025

When Using

Avoid contact with eyes. lf product gets into the eye, flush with Water for 15 minutes.Non-edible.Cap tightly and store at room temperature,away from heat.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/27/2025

Stop Use

Stop use and ask a doctor if discomfort persists.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/27/2025

Ask Doctor

Stop use and ask a doctor if discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/27/2025

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact the Poison Control Center(1-800-222-1222)right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/27/2025

Directions

Wash the affected area. May soak wart in warm water for 5 minutes.Dry area thoroughly. Use a cotton swab to apply a sufficient amount to cover each wart. Let it dry. Repeat this procedure once or twice daily as needed (until wart is removed) for upto 12 weeks.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/27/2025

Other information

Store at room temperature.Avoid excessive heat (37°C/99°F). Skin discoloration may occur during or after use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/27/2025

Inactive ingredients

Water,Polyethylene Glycol,Glycerin,Borneol.

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Reaua BEE VENOM TAG WART REMOVER - FDA Drug Approval Details