SALICYLIC ACID- wart remover gel pen gel

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Harmon Store Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• on irritated, infected or reddened skin
• on genital warts and warts on the face

When using this product

• avoid contact with eyes
• if product gets into the eyes, flush with water for 15 minutes
• avoid inhaling vapors

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.

Directions

• wash affected area
• may soak wart in for 5 minutes
• dry area thoroughly
• remove cap from pen
• remove insert pin from the tip
• twist and click pen until wart remover gel is dispense onto the tip of the applicator. Initial use will require several rotations for the gel to load
• apply a small amount at a time with applicator 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
• for storage ensure applicator is free of excess gel before placing the insert pin back into the tip

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

Harmon

Face Values

Maximum Strength

Wart

Remover

GEL PEN

Salicylic Acid

• Safely Removes Common and Plantar Warts
• No-Drip Gel

1 Prefilled Pen

NET WT 0.04 OZ (1.25 g)

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
wart remover gel pen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.17 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ALCOHOL (UNII: 3K9958V90M)
ETHYL ACETATE (UNII: 76845O8NMZ)
HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PYROXYLIN (UNII: KYR8BR2X6O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-023-04	1.25 g in 1 APPLICATOR; Type 0: Not a Combination Product	09/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	09/01/2015

Labeler - Harmon Store Inc. (804085293)