COMPOUND W TOTAL CARE WART AND SKIN KIT- salicylic acid
HK Kolmar Canada, Inc

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.

----------

Compound W Total Care Wart & Skin Kit

Drug Facts

Active ingredient

Salicylic acid 17% w/w

Purpose

Wart remover

Uses

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

Warnings

For external use only. Flammable. 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, genital warts or warts on the face or mucous membranes.
if you have diabetes or poor blood circulation.

When using this product

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

Stop use and ask a doctor if

discomfort persists.

Keep out of reach of children.

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

Directions

wash affected area
may soak wart in warm water for 5 minutes
dry area thoroughly
by squeezing tube gently, apply one drop at a time to sufficiently cover each wart
let dry
repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Other information

store at room temperature
avoid excessive heat 37°C (99°F)
skin discoloration may accur during or after use
wipe the tip of the tube with a paper towel between uses

Inactive ingredients

alcohol, camphor, castor oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropanol, nitrocellulose, polysorbate 80, water

Questions?

1-800-443-4908 CompoundW.com

Package Labeling:

Outer Package Inner Package

COMPOUND W TOTAL CARE WART AND SKIN KIT
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49354-130

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49354-130-00	1 in 1 KIT	12/05/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	7 g

Part 1 of 1

COMPOUND W WART REMOVER MAXIMUM STRENGTH FAST ACTING
salicylic acid gel

Product Information
Item Code (Source)	NDC:49354-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	170 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CASTOR OIL (UNII: D5340Y2I9G)
ETHYL ACETATE (UNII: 76845O8NMZ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PYROXYLIN (UNII: KYR8BR2X6O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:49354-003-00	1 in 1 CARTON
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/05/2022

Labeler - HK Kolmar Canada, Inc (243501959)

Revised: 12/2022

Document Id: ef3bc3f9-df0e-a8f5-e053-2a95a90aacc2

Set id: def46762-990a-48b0-b702-15ece1dc541f

Version: 1

Effective Time: 20221207

HK Kolmar Canada, Inc