SPL v1
SPL
SPL Set ID 459e8a5a-3e5e-944b-e063-6394a90a90f4
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (170 mg)
Inactive Ingredients
Coptis Chinensis Root Phellodendron Amurense Bark Menthol Glycerin Water Borneol Brucea Javanica Fruit Acorus Calamus Root Triclosan Apis Mellifera Venom Lonicera Japonica Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-10

Description

Drug Facts

Purpose

Wart remover


Medication Information

Purpose

Wart remover

Description

Drug Facts

Uses
  • for the removal of common warts (easily recognized by the rough “cauliflower-like” surface)
  • for the removal of plantar warts (on the bottom of the foot)
Warnings

for external use only

Questions

www.drlukehealthcare.com

Email [email protected]

Directions
  • Soak the wart in warm water for about 15 minutes; dry thoroughly.
  • Using the precision brush, apply a thin layer to cover the wart. Wait until it dries to a film, then apply an extra thin layer if needed.
  • Use twice daily. For larger or thicker warts, more frequent application may be used if needed.
  • After 3 days of continuous use, gently remove the dried film with tweezers, then continue applying.
  • After several days, you may also remove loosened dead skin after soaking; do not cut the wart.
Do Not Use
  • on irritated, infected, or reddened skin
  • on moles, birthmarks, warts with hair, or on the face
  • on genital warts, mucous membranes, or on the nose or lips
  • if you have diabetes or poor blood circulation
  • on broken skin
  • if you are allergic to bee stings/bee venom (product contains bee venom as an inactive ingredient)
  • with any other wart removal product
  • on sensitive areas such as the face, armpits, or private areas
Drug Facts

Drug Facts

Active Ingredient

Salicylic Acid 17%

Other Information
  • Store at 20–25°C (68–77°F). Avoid heat and direct sunlight.
  • Keep bottle tightly closed to prevent evaporation.
  • Tamper evident: Do not use if safety seal is broken or missing.
  • Drying time: normally forms a protective film within 20–30 seconds. In humid or rainy weather, drying may take longer.
Inactive Ingredients

Bee Venom, Water, Brucea javanica, Coptis chinensis, Phellodendron amurense, Acorus calamus, Menthol, Honeysuckle, Triclosan, Borneol, Glycerin.

Principal Display Panel

When Using This Product
  • avoid contact with eyes. If contact occurs, flush with water for 15 minutes.
  • avoid inhaling vapors. Use in a well-ventilated area.
  • transient stinging or mild irritation may occur.
  • do not touch the liquid film until it has completely dried.
Stop Use and Ask A Doctor If
  • discomfort, burning, or irritation persists
  • excessive skin irritation occurs
  • the wart does not improve after 12 weeks of use
  • accidental ingestion occurs
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.
  • Not for use on children under 12 years old.
Ask A Doctor Before Use If You Are
  • pregnant or breastfeeding
  • using any other topical medications on the area

Structured Label Content

Uses
  • for the removal of common warts (easily recognized by the rough “cauliflower-like” surface)
  • for the removal of plantar warts (on the bottom of the foot)
Purpose

Wart remover

Warnings

for external use only

Questions

www.drlukehealthcare.com

Email [email protected]

Directions
  • Soak the wart in warm water for about 15 minutes; dry thoroughly.
  • Using the precision brush, apply a thin layer to cover the wart. Wait until it dries to a film, then apply an extra thin layer if needed.
  • Use twice daily. For larger or thicker warts, more frequent application may be used if needed.
  • After 3 days of continuous use, gently remove the dried film with tweezers, then continue applying.
  • After several days, you may also remove loosened dead skin after soaking; do not cut the wart.
Do Not Use (Do not use)
  • on irritated, infected, or reddened skin
  • on moles, birthmarks, warts with hair, or on the face
  • on genital warts, mucous membranes, or on the nose or lips
  • if you have diabetes or poor blood circulation
  • on broken skin
  • if you are allergic to bee stings/bee venom (product contains bee venom as an inactive ingredient)
  • with any other wart removal product
  • on sensitive areas such as the face, armpits, or private areas
Drug Facts

Drug Facts

Active Ingredient (Active ingredient)

Salicylic Acid 17%

Other Information
  • Store at 20–25°C (68–77°F). Avoid heat and direct sunlight.
  • Keep bottle tightly closed to prevent evaporation.
  • Tamper evident: Do not use if safety seal is broken or missing.
  • Drying time: normally forms a protective film within 20–30 seconds. In humid or rainy weather, drying may take longer.
Inactive Ingredients

Bee Venom, Water, Brucea javanica, Coptis chinensis, Phellodendron amurense, Acorus calamus, Menthol, Honeysuckle, Triclosan, Borneol, Glycerin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, flush with water for 15 minutes.
  • avoid inhaling vapors. Use in a well-ventilated area.
  • transient stinging or mild irritation may occur.
  • do not touch the liquid film until it has completely dried.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • discomfort, burning, or irritation persists
  • excessive skin irritation occurs
  • the wart does not improve after 12 weeks of use
  • accidental ingestion occurs
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, get medical help or contact a Poison Control Center right away.
  • Not for use on children under 12 years old.
Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)
  • pregnant or breastfeeding
  • using any other topical medications on the area

Advanced Ingredient Data


Raw Label Data

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