CLEARCANAL EAR WAX SOFTERNER DROPS- carbamide peroxide 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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Drug Facts

Drug Facts:

Active ingredient: CARBAMIDE PEROXIDE


Ear Wax Removal Drops Directions

Step 1 Ear Wax Removal Drops Directions:

Avoid exposing bottle to excessive heat and direct sunlight. Keep cap on bottle when not in use.

Inactive Ingredients: Glycerin, Oxyquinoline, Aloe Barbadensis, Chamomile

Softens ear wax. Ear wax removal drops

Children under 12 years of age: consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Do not use:

    * If you have had an allergic reaction to Carbamide Peroxide.
    * If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor
    * If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor
    * For more than four consecutive days

Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days

When using this product:

    * Avoid contact with the eyes

Ear Wax Removal Complete System

Ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. When rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax.

The system consists of kit with 1 bottle carbamide peroxide solution 15mL and 1 can sterile saline spray 177mL (or 125mL).


Place 5 to 10 drops of 6.5% carbamide peroxide solution into e

Warnings:
Do not use:
If you have had an allergic reaction to carbamide peroxide.
If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor
If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor
For more than four consecutive days
When using this product:
void contact with the eyes
Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.

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ClearCanal Earwax Removal Kit_Product Label

NeilMed ClearCanal Earwax Removal Kit

CLEARCANAL EAR WAX SOFTERNER DROPS 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-230
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:13709-230-011 in 1 BOX01/02/2012
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:13709-230-101 in 1 KIT08/24/2012
215 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34408/24/2011
Labeler - NeilMed Pharmaceuticals, Inc. (799295915)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals, Inc.799295915manufacture(13709-230)

Revised: 5/2021
Document Id: c1ba4efd-e971-3295-e053-2995a90a0fee
Set id: 0ef2be5b-cc39-48ae-b5c5-e787464dea08
Version: 6
Effective Time: 20210507
 
NeilMed Pharmaceuticals, Inc.