COMPOUND W- salicylic acid gel

Compound W by

Drug Labeling and Warnings

Compound W by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Compound W®
Salicylic Acid Wart Remover

MAXIMUM STRENGTH
FAST ACTING GEL

NET WT 0.25 OZ (7 g)

Drug Facts

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 on the surface.
  
• the 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 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

Inactive ingredients

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

Questions?

1-800-443-4908 CompoundW.com

©2016 Distributed by Medtech Products Inc.
Tarrytown, NY 10591
A Prestige Brands Company
Made in Brazil

PRINCIPAL DISPLAY PANEL - 7 gm Tube Box Label

CommUnityCare Federally Qualified Health Centers

COMPOUND
W GEL 7 GM

Date:

Name:
Dr.

APPLY 1 DROP TO CLEAN, DRY WART 1-2 TIMES DAILY.
REPEAT UP TO 12 WEEKS.

1-1-11

123456

Compound W GEL 7gm NDC: 76413-348-07

Batch: 123456
Lot: 123456
Exp: 1-1-11
MEDTECH

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

INGREDIENTS AND APPEARANCE

COMPOUND W 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-348(NDC:63029-595)
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
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CASTOR OIL (UNII: D5340Y2I9G)
ETHYL ACETATE (UNII: 76845O8NMZ)
HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)
HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PYROXYLIN (UNII: KYR8BR2X6O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-348-07	1 in 1 BOX	11/30/2017
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358B	03/15/2014

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-348) , RELABEL(76413-348)