CLEANSE RIGHT EAR WAX DROPS- ear wax drops solution/ drops

Cleanse Right Ear Wax Drops by

Drug Labeling and Warnings

Cleanse Right Ear Wax Drops by is a Otc medication manufactured, distributed, or labeled by Blue Echo Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Carbamide Peroxide 6.5%

PURPOSE

Purpose

Ear Wax Removal Aid

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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 INGREDIENT

Inactive Ingredients

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

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEANSE RIGHT EAR WAX DROPS 
ear wax drops solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73117-111(NDC:15579-840)
Route of Administration	IRRIGATION

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
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73117-111-05	1 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2022
2	NDC: 73117-111-10	1 mL in 1 KIT; Type 0: Not a Combination Product	09/07/2022
3	NDC: 73117-111-15	1 mL in 1 KIT; Type 0: Not a Combination Product	02/15/2023
4	NDC: 73117-111-70	1 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	09/07/2022

Labeler - Blue Echo Care (117048847)

Establishment
Name	Address	ID/FEI	Business Operations
Blue Echo Care		117048847	relabel(73117-111)