SUAVEAR- suavear solution/ drops 
NeilMed Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SuavEar

SuavEar active ingredientCarbamide Peroxide 6.5%

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

Whe using this product avoid contact with the eyes.

Stop use and ask a doctor if

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.

Package Label

SUAVEAR 
suavear solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-233
Route of AdministrationAURICULAR (OTIC)
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
GLYCERIN (UNII: PDC6A3C0OX)  
OXYQUINOLINE (UNII: 5UTX5635HP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-233-0115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/09/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/09/2016
Labeler - NeilMed Pharmaceuticals Inc. (783557783)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals, Inc.799295915manufacture(13709-233)

Revised: 3/2016
Document Id: 663bae1b-c8e4-104a-e053-2991aa0a4edf
Set id: 663bae1b-c8e3-104a-e053-2991aa0a4edf
Version: 1
Effective Time: 20160309
 
NeilMed Pharmaceuticals Inc.