PRORINSE EARWAX REMOVAL SYSTEM- carbamide peroxide solution/ drops

ProRinse Earwax Removal System by

Drug Labeling and Warnings

ProRinse Earwax Removal System by is a Otc medication manufactured, distributed, or labeled by McKeon Products Inc, Bell Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

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 or pharmacist before use if you have:

• ear drainage or discharge
• recently had ear surgery
• dizziness
• pain, irritation, or rash in the ear
• an ear infection
• had an injury or perforation (hole) of the eardrum

Stop use and ask doctor if:

• you need to use for more than four days
• excessive earwax remains after use of this product

When using this product, avoid contact with the eyes

When using earplugs, do not insert deeply into ear canal. Remove very slowly with a twisting motion to gradually break the seal. Due to the excellent seal characteristics, rapid removal may damage eardrum

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and Children over 12 years of age:

• Tilt head sideways and place 5 to 10 Earwax Removal Drops into ear

Tip of applicator nozzle should NOT enter ear canal

• With head still sideways, insert earplugs as follows:

Reach over head and pull up and back on outer ear to straighten ear canal

With opposite hand, grasp earplug stem and insert by pressing forward in a circular motion, just enough to seal in drops. Do not insert deeply into canal.

• Repeat for other ear, if treating both ears
• Keep drops in ear(s) for several minutes
• Remove earplugs slowly with a twisting motion to gradually break the seal
• Use twice daily for up to four days if needed, or as directed by a doctor
• Any earwax remaining after the 4-day treatment may be removed by gently rinsing the ear with body-temperature water, using the Bellow Syringe

Fill supplied tub 1/3 to 1/2 full with body-temperature water

Fully compress Bellow Syringe and insert blue Rinse Tip into water

Release the pressure on the Bellow Syringe, allowing the water to be drawn into the bellow

While holding tub beneath ear, place the blue Rinse Tip into ear opening and compress bellow to rinse ear canal

Children under 12 years of age: Consult a doctor

Other information

• Avoid exposing Earwax Removal Drops to excessive heat and sunlight
• Ear drops foam on contact with earwax due to release of oxygen. There may be an associated “crackling” sound
• Keep cap on bottle when not in use
• This system is designed for multiple treatments
• The components are washable and reusable

Inactive ingredients

• anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions or comments?

Call (586) 427-7560 during business hours (EST)

Product label

INGREDIENTS AND APPEARANCE

PRORINSE EARWAX REMOVAL SYSTEM 
carbamide peroxide solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66354-007
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	65 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66354-007-82	1 in 1 BOX	02/05/2026
1		15 mL in 1 BOTTLE; 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	02/05/2026

Labeler - McKeon Products Inc (006522122)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals, Inc.		140653770	manufacture(66354-007)