Genital Wart Remover Ointment. by Consilii LLC 83299-009 Completed

Genital Wart Remover Ointment. by

Drug Labeling and Warnings

Genital Wart Remover Ointment. by is a Otc medication manufactured, distributed, or labeled by Consilii LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENITAL WART REMOVER OINTMENT.- genital wart remover cream cream 
Consilii LLC

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83299-009 Completed

Active Ingredient

Salicylic acid 1%
Chlorhexidine di(acetate) 1%

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 reddened
on moles, birthmarks, warts with hair growing from them, warts on the face or mucous membranes

When Using

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

Stop Use

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

Ask Doctor

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

Keep Oot Of Reach Of Children

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(cotton swab), apply a layer of ointment to sufficiently cover each wart
allow it to fully absorb and cover it with a bandage as needed.
repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks

Inactive ingredients

Alcohol, Borneol, Carthamus tinctorius l., Cetostearyl alcohol, Cnidium monnieri, Cortex dictamni, Fructus kochiae scopariae, Fructus xanthii, Houttuynia cordata thunb., Isatis indigotica fortune, Lonicera japonica thunb, Radix isatidis, Sophora flavescens, Thenardite

Questions

1 914-608-1258

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

GENITAL WART REMOVER OINTMENT. 
genital wart remover cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83299-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROACETIC ACID (UNII: 5GD84Y125G) (CHLOROACETIC ACID - UNII:5GD84Y125G)	CHLOROACETIC ACID	1 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)
HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)
SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
BORNEOL (UNII: M89NIB437X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
LONICERA JAPONICA WHOLE (UNII: UV4X7MQQ43)
CABBAGE (UNII: GW0W1Y9I97)
ALCOHOL (UNII: 3K9958V90M)
XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C)
CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83299-009-01	20 g in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/29/2023	11/21/2024

Labeler - Consilii LLC (118891890)

Establishment
Name	Address	ID/FEI	Business Operations
Consilii LLC		118891890	label(83299-009) , manufacture(83299-009)

Revised: 11/2024

Document Id: 2763c017-bfbe-050a-e063-6294a90acd3d

34390-5

Set id: ff501036-6ff2-0073-e053-6394a90a411f

Version: 2

Effective Time: 20241120

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