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 NuCare Pharmaceuticals,Inc.. 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 - Carton label 0.5 FL OZ

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66267-976(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: 66267-976-15	15 mL in 1 BOX; Type 0: Not a Combination Product	05/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	05/27/2014

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals,Inc.		010632300	relabel(66267-976)