TOPCARE EARWAX REMOVAL KIT- carbamide peroxide liquid

TopCare Earwax Removal Kit by

Drug Labeling and Warnings

TopCare Earwax Removal Kit by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, Bell Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, looser, and remove excessive earwax

Warnings

For use in the ear only

Ask a doctor before use if you have

• Ear drainage or discharge
• Ear pain
• Irritation, or rash in the ear
• Dizziness
• An injury or perforation (hole) of the ear drum
• Recently had ear surgery

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

• You need to use for more than 4 days
• Excessive earwax remains after use of this product

Keep out of reach of children

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

Directions

FOR USE IN THE EAR ONLY
Adults and children over 12 years of age:

• Tilt head sideways and place 5 to 10 drops into ear
• Tip of applicator should not enter ear canal
• Keep drops in ear for several minutes by keeping head titled or placing cotton in the ear
• Use twice daily for up to 4 days if needed, or as directed by a doctor
• Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

Children under 12 years: consult a doctor

Other information

• Avoid exposing bottle to excessive heat and direct sunlight
• Store bottle in the outer carton
• Keep cap on bottle when not in use
• Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound
• Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

1-800-328-5890

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Distributed By Topco Associates LLC  ELK Frove Village, IL 60007  Topco  BPH414  Questions? 1-888-423-0139  topcare@topco.com

PRINCIPAL DISPLAY PANEL

Top Care  Earwax Removal Aid  Earwax Removal Kit Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating  Washer Bulb  Included  Compare to Derbox  active ingredient  0.5 FL OZ (15 mL)

Product Labels

INGREDIENTS AND APPEARANCE

TOPCARE EARWAX REMOVAL KIT 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-835
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-835-33	1 in 1 CARTON	11/28/2014
1		15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	11/28/2014

Labeler - TOPCO ASSOCIATES LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals, Inc.		140653770	manufacture(36800-835)