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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

01

GENITAL WART REMOVER OINTMENT. 
genital wart remover cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROACETIC ACID (UNII: 5GD84Y125G) (CHLOROACETIC ACID - UNII:5GD84Y125G) CHLOROACETIC ACID1 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)  
HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)  
SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)  
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
BORNEOL (UNII: M89NIB437X)  
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
LONICERA JAPONICA WHOLE (UNII: UV4X7MQQ43)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALCOHOL (UNII: 3K9958V90M)  
XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C)  
CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX)  
CABBAGE (UNII: GW0W1Y9I97)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83299-009-0120 g in 1 BOTTLE; Type 0: Not a Combination Product06/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01606/29/2023
Labeler - Consilii LLC (118891890)
Establishment
NameAddressID/FEIBusiness Operations
Consilii LLC118891890label(83299-009) , manufacture(83299-009)

Revised: 6/2023
Document Id: ff501036-6ff3-0073-e053-6394a90a411f
Set id: ff501036-6ff2-0073-e053-6394a90a411f
Version: 1
Effective Time: 20230629
 
Consilii LLC