SUAVEAR EARWAX REMOVAL AID- earwax removal aid solution/ drops

SuavEar Earwax Removal Aid by

Drug Labeling and Warnings

SuavEar Earwax Removal Aid by is a Otc medication manufactured, distributed, or labeled by NEILMED 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 earwax

Warnings

Ask a doctor before use if you have

• Ear drainage or discharge
• Ear Pain
• Irritation or rash in the ear
• Dizziness
• An injury or perforation (hole) of the eardrum
• Recently had ear surgery

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

• You need to use for more than 3 days in a row

Keep this and all drugs 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 12 years of age:

• Tilt head sideways
• Place 5 to 10 drops into the ear, making sure that the tip of the applicator does not enter the earcanal
• Keep drops in the ear for sevaral minutes, either by using teh included earplugs or keeping the head tilted to the side
• Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the enclosed soft silicone bulb
• Use twice daily for upto four days, or as directed by a doctor

Children under 12 years: consult a doctor

Other Information

• Store bottle in the outer carton
• Product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound.
• Keep cap on bottle when not in use

Inactive Ingredients

Glycerin

Oxyquinoline

Product label : SuavEar Earwax Removal Aid

INGREDIENTS AND APPEARANCE

SUAVEAR EARWAX REMOVAL AID 
earwax removal aid solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-312
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
GLYCERIN (UNII: PDC6A3C0OX)
OXYQUINOLINE (UNII: 5UTX5635HP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-312-01	1 in 1 KIT	04/22/2021
1		15 mL in 1 BOTTLE, DROPPER; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	04/22/2021

Labeler - NEILMED PHARMACEUTICALS INC (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NEILMED PHARMACEUTICALS INC		799295915	manufacture(13709-312)