WALGREENS EAR WAX REMOVER- carbamide peroxide 6.5% liquid

Walgreens Ear Wax Remover by

Drug Labeling and Warnings

Walgreens Ear Wax Remover by is a Otc medication manufactured, distributed, or labeled by Walgreens Company, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient 

Carbamide Peroxide 6.5%

Purpose 

Ear Wax Removal Aid

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings 

Ask a Doctor before use if you have

• eardrainage, discharge, ear pain,irritation
• rash in the ear,or are dizzy
• injury or perforation (hole) of the ear drum
• Recently had ear surgery

Stop Use and ask a Doctor if

• you need to use for more than 4 days
• execessive ear wax remain after use of this product

When using this product

do not use for more than four days
avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
if excessive earwax remains after the use of this product, consult a doctor

Keep out of the 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
• When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

Children under 12 years: consult a doctor.

Inactive Ingredients 

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Other information 

Protect from heat and direct sunlight
product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
Keep cap on bottle when not in use.
Lot No. and EXP date: see label, bottom container or box.

Principal Display Panel Bottle Label 0.5 FL OZ

Walgreens Ear Wax Remover  NDC: 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Carton Label 0.5 FL OZ

Walgreens Ear Wax Remover NDC: 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Kit Label 0.5 FL OZ

Walgreens Ear Wax Remover Kit  NDC: 0363-2068-25

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

INGREDIENTS AND APPEARANCE

WALGREENS EAR WAX REMOVER 
carbamide peroxide 6.5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-2068
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	0.065 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-2068-15	1 in 1 CARTON	04/28/2014
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0363-2068-25	1 in 1 KIT	04/28/2014
2		15 mL in 1 BOTTLE, DROPPER; 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	04/28/2014

Labeler - Walgreens Company (008965063)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(0363-2068)