SALICYLIC ACID- wart remover gel pen gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
CVS Pharmacy
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Wart remover - for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface - Plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern
Authorization status:
OTC monograph final
Authorization number:
59779-185-04

SALICYLIC ACID- wart remover gel pen gel

CVS Pharmacy

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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Wart Remover Gel Pen

Active ingredient

Salicylic acid 17%w/w

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

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.

Flammable

keep away from fire or flame

Do not use

if you are a diabetic or have poor blood circulation, except under the advice and supervision of a

doctor or podiatrist

on moles, birthmarks and warts with hair growing from them

on mucous membranes such as nose, anus, genitals and lips

on irritated, infected or reddened skin

on genital warts and warts on the face

Ask doctor before use if you have:

diabetes

poor blood circulation

When using this product

avoid contact with eyes

avoid inhaling vapors

if product gets into the eyes, flush with water for 15 minutes

Stop use and consult a doctor if

discomfort persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

after washing affected area

may soak wart in warm water for 5 minutes

dry area thoroughly

remove cap from pen

remove insert pin from the tip and discard

twist and click pen until wart remover gel is dispensed onto the tip of the applicator. Initial use will

require several rotations for the gel to load

apply a small amount at a to sufficiently cover each wart

let dry

repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks

for storage, ensure applicator is free of excess gel before placing the cap back on

keep outer package for complete Drug Facts information

Other information

store between 59°F to 86°F (15°C to 30°C)

if gel hardens at tip of applicator, dispense product and remove blockage

Inactive ingredients

camphor, castro oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropyl alcohol,

nitrocellulose, polysorbate 80, SDA 3C ethyl alcohol

Questions?

call 1-866-964-0939

Principal Display Panel

CVS Health

MAXIMUM STRENGTH

Wart Remover Gel Pen

SALICYLIC ACID

Safely removes common and plantar warts

No-drip gel

1 PRE-FILLED PEN

Net WT .04 OZ (1.25g)

SALICYLIC ACID

wart remover gel pen gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 779 -18 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

0 .21 g in 1.25 g

Inactive Ingredients

CVS Pharmacy

Ingredient Name

Stre ng th

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ETHYL ACETATE (UNII: 76 8 45O8 NMZ)

HYPO PHO SPHO RO US ACID (UNII: 8 B1RL9 B4ZJ)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PYRO XYLIN (UNII: KYR8 BR2X6 O)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:59 779 -18 5-

1.25 g in 1 APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

10 /0 1/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 B

10 /0 1/20 14

Labeler -

CVS Pharmacy (062312574)

Revised: 5/2019

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