DUOFILM WART REMOVER- salicylic acid liquid
Schering-Plough HealthCare Products, 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.

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Drug Facts

Active ingredient

Salicylic acid 17%

Purpose

Wart Remover

Uses

for removal of common and plantar warts
common warts can be easily recognized by the rough cauliflower-like appearance of the surface
plantar warts can be 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

Flammable Keep away from fire or flame

Do not use

if you have diabetes
if you have poor blood circulation
on irritated skin or 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

When using this product

if product gets in eyes, flush with water for 15 minutes.
do not inhale vapors
cap bottle tightly when not in use and store at room temperature away from heat

Stop use and ask a doctor if discomfort lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wash affected area
may soak wart in warm water for 5 minutes
dry thoroughly
apply one drop at a time with applicator to sufficiently cover each wart
let dry
self-adhesive cover-up discs may be used to conceal wart
repeat procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

castor oil, ethyl lactate, flexible collodion, polybutene. (Contains alcohol 18% v/v and ether 53%v/v from the flexible collodion).

PRINCIPAL DISPLAY PANEL - 9.8 mL Bottle Carton

LIQUID

Schering-Plough

DuoFilm®
SALICYLIC ACID WART REMOVER

Safe and reliable removal of
common and plantar warts
Cover-up discs protect warts
as they heal

1/3 FL OZ (9.8 mL)
20 cover-up discs

DUOFILM WART REMOVER
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-0635
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (Salicylic Acid)	Salicylic Acid	1.7 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
castor oil
ethyl lactate
alcohol
ether

Product Characteristics
Color	YELLOW (clear yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:11523-0635-2	1 in 1 CARTON
1		9.8 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358B	08/14/1990

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)

Revised: 02/2011

Document Id: 0db1af4f-8d90-42e0-adfa-c535943fb7b1

Set id: 741f5e19-2bea-4adf-9ae2-204bff127536

Version: 1

Effective Time: 20110204

Schering-Plough HealthCare Products, Inc.