SuavEar by NeilMed Pharmaceuticals Inc. / NeilMed Pharmaceuticals, Inc. SUAVEAR solution/ drops

SuavEar by

Drug Labeling and Warnings

SuavEar by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals Inc., NeilMed Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SuavEar

Carbamide Peroxide 6.5%

DOSAGE & ADMINISTRATION

For use in the ear only.

Tilt head sideways. Place 5 to 10 drops in the ear, making sure that the tip of the applicator does not enter the ear canal. Keep drops in the ear for several minutes, either by using the included ear plugs 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 up to four days, or as directed by the doctor.

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) in the eardrum
• Recently had ear surgery

Whe using this product avoid contact with the eyes.

Stop use and ask a doctor if

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

List of inactive ingredients

Glycerin, Oxyquinoline

Ear canal cleaning

For occasional aid to soften, loosen and remove excessive earwax

Purpose

For occasional aid to soften, loosen and remove excessive earwax.

Keep out of reach of children.

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUAVEAR 
suavear solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-233
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: 13709-233-01	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/09/2016

Labeler - NeilMed Pharmaceuticals Inc. (783557783)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals, Inc.		799295915	manufacture(13709-233)