Drug Facts

Active ingredients

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 flusing 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
Produt foams on contact with earwax due to release of oxygen. There may be an associated crakling 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:

Label2

FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB
carbamide peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-835

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55319-835-01	1 in 1 KIT	11/01/2019

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

Part 1 of 1

FAMILY WELLNESS EARWAX REMOVAL
carbamide peroxide solution/ drops

Product Information
Route of Administration	AURICULAR (OTIC)

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

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

#	Item Code	Package Description
Packaging
1	NDC:55319-836-01	1 in 1 BOX
1		15 mL in 1 PACKAGE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M014	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M014	11/01/2019

Labeler - Family Dollar Services Inc (024472631)

Name	Address	ID/FEI	Business Operations
Establishment
Bell Pharmaceuticals, Inc.		140653770	manufacture(55319-835)

Family Wellness-Earwax Removal Kit, Earwax & Bulb