ClearCanal NeilMed

Dosage form: solution/ drops
Ingredients: CARBAMIDE PEROXIDE 65mg in 1mL
Labeler: NeilMed Pharmaceuticals, Inc.
NDC Code: 13709-230

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.

Drug Facts

Drug Facts:

Active ingredient: CARBAMIDE PEROXIDE


Ear Wax Removal Drops Directions

Step 1 Ear Wax Removal Drops Directions:

  • FOR USE IN THE EAR ONLY.
  • Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear.
  • Tip of applicator should not enter ear canal.
  • Keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear.
  • Use twice daily for upto 4 days if needed or as directed by a doctor.
  • Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter.
  • Children under 12 years of age: consult a doctor.

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:

  • Avoid contact with the eyes
  • Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.

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.

Enter 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 
Packaging
#Item CodePackage Description
1NDC:13709-230-021 BOTTLE, DROPPER (BOTTLE) in 1 BOX
1NDC:13709-230-0115 mL in 1 BOTTLE, DROPPER
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: 03/2012
 
NeilMed Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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