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 GeriCare Pharmaceutical Corp, 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

Do not use if you have 

• eardrainage, discharge, ear pain,irritation
• rashin the ear,or are dizzy
• injuryor perforation (hole) of the ear drum or after ear surgery

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 
• 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 0.5 FL OZ

Preferred Plus Pharmacy

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel - Carton label 0.5 FL OZ

Preferred  Plus Pharmacy

Ear wax Remover Drops 

Carbamide Peroxide 6.5%

Ear wax removal aid 

0.5 FL OZ ( 15ml)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-339
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: 57896-339-05	1 in 1 CARTON	05/27/2014
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 final	part344	05/27/2014

Labeler - GeriCare Pharmaceutical Corp (611196254)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(57896-339)