SALICYLIC ACID- wart remover gel gel

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 and flame

Do not use

• on moles, birth marks 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
• if you are diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist

When using this product

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

Keep out of reach of children.

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

if discomfort persists

see your doctor or podiatrist.

Directions

• after washing affected area, soak wart in for 5 minutes in comfortably warm water
• dry area thoroughly
• apply one drop of gel at a time to sufficiently cover each wart
• let dry
• repeat this procedure once or twice daily (until wart is removed) for up to 12 weeks

Other information

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

Inactive ingredients

camphor, castor 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

TopCare health

MAXIMUM STRENGTH
WART

Remover

Gel
SALICYLIC ACID 17%

• Safely Removes Common & Plantar Warts
• Convenient & Easy
• No Drip Formula

NET WT 0.25 OZ (7g)

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
wart remover gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-043
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 7 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ALCOHOL (UNII: 3K9958V90M)
ETHYL ACETATE (UNII: 76845O8NMZ)
HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PYROXYLIN (UNII: KYR8BR2X6O)
CASTOR OIL (UNII: D5340Y2I9G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-043-25	7 g in 1 TUBE; Type 0: Not a Combination Product	10/07/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	10/07/2014

Labeler - Topco Associates LLC (006935977)

Registrant - Premier Brands of America Inc. (063849780)

Establishment
Name	Address	ID/FEI	Business Operations
Alchemix Corporation		615263956	manufacture(36800-043)