CLEANSE RIGHT EAR WAX DROPS- ear wax drops solution/ drops 
Blue Echo Care

----------

Active ingredient

Carbamide Peroxide 6.5%

Purpose

Ear Wax Removal Aid

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, Sodium Citrate Dihyfrate, Sodium Lauryl Sulfate, Glycerin, Propylene Glycol, Purified Water

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.

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

Carbamide Peroxide 6.5

CLEANSE RIGHT EAR WAX DROPS 
ear wax drops solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73117-111(NDC:15579-840)
Route of AdministrationIRRIGATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73117-111-051 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/2022
2NDC:73117-111-101 mL in 1 KIT; Type 0: Not a Combination Product09/07/2022
3NDC:73117-111-151 mL in 1 KIT; Type 0: Not a Combination Product02/15/2023
4NDC:73117-111-701 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2023
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01409/07/2022
Labeler - Blue Echo Care (117048847)
Establishment
NameAddressID/FEIBusiness Operations
Blue Echo Care117048847relabel(73117-111)

Revised: 2/2024
Document Id: 08a1ade1-5675-7393-e063-6394a90a158d
Set id: e81e5a3a-b71d-7f8b-e053-2a95a90a3a48
Version: 4
Effective Time: 20240202
 
Blue Echo Care