EAR WAX REMOVAL DROPS- carbamide peroxide - 6.5% solution/ drops

Ear Wax Removal Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Carbamide Peroxide 6.5%

Purpose 

Earwax 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.

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.

Inactive Ingredients 

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

Principal Display Panel -Bottle Label 

Sheffield       

Earwax Removal Aid Drops 

Carbamide Peroxide 6.5%

NET 0.5 FLOZ (15 ml )

INGREDIENTS AND APPEARANCE

EAR WAX REMOVAL DROPS 
carbamide peroxide - 6.5% solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-143
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
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: 11527-143-51	1 in 1 CARTON	02/02/2017
1		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 Drug	M014	02/02/2017

Labeler - Sheffield Pharmaceuticals LLC (151177797)