SUAVEAR EARWAX REMOVAL AID- earwax removal aid solution/ drops 
NEILMED PHARMACEUTICALS INC

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New Neilmed SuavEar Earwax Removal Aid

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

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

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:

Children under 12 years: consult a doctor

Other Information

Inactive Ingredients

Glycerin

Oxyquinoline

Product label : SuavEar Earwax Removal Aid

Suavear

SUAVEAR EARWAX REMOVAL AID 
earwax removal aid solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-312
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:13709-312-011 in 1 KIT04/22/2021
115 mL in 1 BOTTLE, DROPPER; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01404/22/2021
Labeler - NEILMED PHARMACEUTICALS INC (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NEILMED PHARMACEUTICALS INC799295915manufacture(13709-312)

Revised: 1/2024
Document Id: 0eb0ee15-bb9f-bd77-e063-6394a90a0df7
Set id: c067f1a4-1f67-3f4d-e053-2a95a90a6095
Version: 2
Effective Time: 20240111
 
NEILMED PHARMACEUTICALS INC