83818-012

83818-012
SPL v1
SPL
SPL Set ID 35ca9836-917a-b0ac-e063-6294a90a28a2
Route
TOPICAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Thuja Occidentalis Whole (2 g) Apis Mellifera Venom Calendula Officinalis Flower
Inactive Ingredients
Phellodendron Chinense Whole Melissa Officinalis Whole Salicylic Acid Citrus Limon (lemon) Peel Oil Melaleuca Alternifolia (tea Tree) Leaf Oil Prunus Amygdalus Dulcis (sweet Almond) Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-23

Description

Calendula officinalis 2% Thuja occidentalis 2% Apis mellifera venom 2%

Purpose

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


Medication Information

Purpose

Calendula officinalis ……healing agent

Thuja occidentalis………polyps, skin overgrowths

Apis mellifera venom……skin tag and wart remover

Description

Calendula officinalis 2% Thuja occidentalis 2% Apis mellifera venom 2%

Use

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

Stop Use

Stop use and ask a doctor if

1.Irritation occurs

2.symptoms worsen after 7 days

Warnings

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

Ask Doctor

Stop use and ask a doctor if

1.Irritation occurs

2.symptoms worsen after 7 days

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

Do Not Use

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

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.

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.

Active Ingredient

Calendula officinalis 2%

Thuja occidentalis 2%

Apis mellifera venom 2%

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 Ingredients

PHELLODENDRON CHINENSIS WHOLE

CITRUS LIMON (LEMON) PEEL OIL

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

MELISSA OFFICINALIS WHOLE

SWEET ALMOND OIL

SALICYLIC ACID

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

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

Purpose

Calendula officinalis ……healing agent

Thuja occidentalis………polyps, skin overgrowths

Apis mellifera venom……skin tag and wart remover

Stop Use

Stop use and ask a doctor if

1.Irritation occurs

2.symptoms worsen after 7 days

Warnings

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

Ask Doctor

Stop use and ask a doctor if

1.Irritation occurs

2.symptoms worsen after 7 days

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

Do Not Use (Do not use)

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

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.

What to Expect (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.

Active Ingredient

Calendula officinalis 2%

Thuja occidentalis 2%

Apis mellifera venom 2%

Other Information (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 Ingredients (Inactive ingredients)

PHELLODENDRON CHINENSIS WHOLE

CITRUS LIMON (LEMON) PEEL OIL

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

MELISSA OFFICINALIS WHOLE

SWEET ALMOND OIL

SALICYLIC ACID

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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