CAREONE EARWAX REMOVAL KIT, EARWAX AND BULB- carbamide peroxide kit

CareOne Earwax Removal Kit, Earwax and Bulb by

Drug Labeling and Warnings

CareOne Earwax Removal Kit, Earwax and Bulb by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, 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, loosen, 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 tilted 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

SPL UNCLASSIFIED SECTION

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

Package Labeling:

INGREDIENTS AND APPEARANCE

CAREONE EARWAX REMOVAL KIT, EARWAX AND BULB 
carbamide peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-836

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-836-33	1 in 1 KIT	01/01/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL

Part 1 of 1

CAREONE EARWAX REMOVAL DROPS 
carbamide peroxide solution/ drops

Product Information
Item Code (Source)	NDC: 72476-835
Route of Administration	AURICULAR (OTIC)

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: 72476-835-33	1 in 1 BOX
1		15 mL in 1 BOTTLE; 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	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	01/01/2020

Labeler - Retail Business Services, LLC (967989935)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals, Inc.		140653770	manufacture(72476-836) , label(72476-835)