CLEARCANAL  NEILMED - 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:

Active ingredient: CARBAMIDE PEROXIDE


Ear Wax Removal Drops Directions

Step 1 Ear Wax Removal Drops Directions:

Warnings:


Do not use:

When using this product:


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 ear.

image of kit label

image of bottle labelEnter section text here


CLEARCANAL   NEILMED
ear wax removal complete kit solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-230
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (CARBAMIDE PEROXIDE) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Oxyquinoline 
Chamomile Flower Oil 
Aloe 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:13709-230-021 BOTTLE, DROPPER ( BOTTLE) in 1 BOXcontains a BOTTLE, DROPPER (13709-230-01)
1NDC:13709-230-0115 mL in 1 BOTTLE, DROPPERThis package is contained within the BOX (13709-230-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34408/24/2011

Labeler - NeilMed Pharmaceuticals, Inc. (783557783)
Establishment
NameAddressID/FEIOperations
NeilMed Pharmaceuticals, Inc.783557783manufacture

Revised: 01/2012 NeilMed Pharmaceuticals, Inc.