MedPath

SupreH Bee Venom Skin Tag Treatment Liquid

83818-012

Approved
Approval ID

35ca9836-917a-b0ac-e063-6294a90a28a2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Shenzhen Xinxin Yunhai Technology Co., Ltd.

DUNS: 699816806

Products 1

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

SupreH Bee Venom Skin Tag Remover Liquid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83818-012
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
SupreH Bee Venom Skin Tag Remover Liquid
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (9)

PHELLODENDRON CHINENSE WHOLEInactive
Code: QKA3ZK8IIE
Classification: IACT
MELISSA OFFICINALIS WHOLEInactive
Code: YF70189L0N
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
THUJA OCCIDENTALIS WHOLEActive
Quantity: 2 g in 100 mL
Code: 5HBV6WCE3N
Classification: ACTIB
APIS MELLIFERA VENOMActive
Quantity: 2 g in 100 mL
Code: 76013O881M
Classification: ACTIB
CITRUS LIMON (LEMON) PEEL OILInactive
Code: I9GRO824LL
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILInactive
Code: 66YXD4DKO9
Classification: IACT
CALENDULA OFFICINALIS FLOWERActive
Quantity: 2 g in 100 mL
Code: P0M7O4Y7YD
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Use

for the temporary relief of symptoms associated with skin tags such as overgrowths and polyps

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active Ingredient

Calendula officinalis 2%

Thuja occidentalis 2%

Apis mellifera venom 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purpose

Calendula officinalis ……healing agent
Thuja occidentalis………polyps, skin overgrowths
Apis mellifera venom……skin tag and wart remover

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

Warnings

For external use only. Do not use this product on irritated skin, or on open wounds. Perform skin test prior to initial use.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

Do not use

Do not use it if pregnant or breastfeeding. Keep out of reach of children.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/23/2025

When Using

When using this product, keep away from eyes & mucous membranes. If swallowed get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/23/2025

Stop Use

Stop use and ask a doctor if
1.Irritation occurs
2.symptoms worsen after 7 days

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/23/2025

Ask Doctor

Stop use and ask a doctor if
1.Irritation occurs
2.symptoms worsen after 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/23/2025

Keep Out Of Reach Of Children

Please keep out of reach of children. If children accidentally swallow it, please call the emergency center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Directions

Adult s & children 4 years and over:
Wash hands before & after use. Shake well& apply 1 or 2 drops to a cotton swab and dab directly to the tags 3 times daily. Do not oversaturate or exceed dosage. It is important not to miss applications.

Children under 4 yrs: Do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/23/2025

Other information

Keep away from extreme heat. Store in a cool, dry place. Do not use if tamper- evident seal is broken or missing.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients

PHELLODENDRON CHINENSIS WHOLE
CITRUS LIMON (LEMON) PEEL OIL
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
MELISSA OFFICINALIS WHOLE
SWEET ALMOND OIL
SALICYLIC ACID

DESCRIPTION SECTION

LOINC: 34089-3Updated: 5/23/2025

What to expect

Skin tags generally flake away within 2-6 weeks (a little longer for stubborn strains). At first you may not notice any change. The formula works from the base upwards. The tags may change in color and/or appearance, this is normal and part of the process. Be patient and persist with applications.

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SupreH Bee Venom Skin Tag Treatment Liquid - FDA Drug Approval Details