WART REMOVER by Consilii LLC 83299-001 Completed

WART REMOVER by

Drug Labeling and Warnings

WART REMOVER by is a Otc medication manufactured, distributed, or labeled by Consilii LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WART REMOVER- wart remover liquid 
Consilii LLC

----------

83299-001 Completed

Active Ingredient(s)

Salicylic acid 12%

Purpose

Wart remover

Use

for the removal of common and plantar warts
the common wart is easily recognized by the rough "cauliflower-like" appearance of the surface
the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern

Warnings

For external use only.
Keep away from fire and flame.

Do not use

on irritated skin or on any area that is infected or reddenede
on moles, birthmarks, warts with hair growing from them, warts on the face or mucous membranes

avoid contact with eyes. If the product gets into the eye,flush with water for 15 minutes
avoid inhaling vapors
cap the bottle tightly
out of direct sunlight and store at room temperature away from heat

if discomfort persists.
if you have diabetes or poor blood circulation.

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

Directions

wash the affected area
may soak the wart in warm water for 5 minutes
dry area thoroughly
using the applicator(brush or cotton swab), apply one drop at a time to sufficiently cover each wart
allow it to fully absorb and let dry
repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks

Other information

Keep away from direct sunlight or heat.

Store at room tempetature 15°-30°C (59°-86°F)

Inactive ingredients

Cnidium monnieri, Podophyllum, Hawthorn, Stellera chamaejasm, Sophora flavescens, Earthy hibiscus bark, Honeysuckle

Stop use and ask a doctor

if discomfort persists.
if you have diabetes or poor blood circulation.

1-914-608-1258

Package Label - Principal Display Panel

WART REMOVER 
wart remover liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83299-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	12 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LONICERA CONFUSA FLOWER (UNII: 3JV904IJ0V)
SOPHORA PACHYCARPA WHOLE (UNII: 4E0W7M7OOQ)
AGERATINA HERBACEA WHOLE (UNII: 1VI0ZA82GD)
PODOPHYLLUM HEXANDRUM ROOT (UNII: 4YOL15R9R8)
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36)
THYME (UNII: CW657OBU4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83299-001-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M028	02/15/2023	11/21/2024

Labeler - Consilii LLC (118891890)

Establishment
Name	Address	ID/FEI	Business Operations
Consilii LLC		118891890	manufacture(83299-001) , label(83299-001)

Revised: 11/2024

Document Id: 2763b5cc-4515-a39b-e063-6394a90aa63b

34390-5

Set id: f57c1dd5-3ac6-8e1f-e053-2995a90ac886

Version: 3

Effective Time: 20241120

 <