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ClearCanal

NeilMed Pharmaceuticals, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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:




  • 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


  • 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

Purpose

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.

ClearCanal

ClearCanalEnter section text here

ClearCanal

Ear Wax Removal Complete Kit SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13709-230
Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE 65 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
Oxyquinoline
CHAMOMILE FLOWER OIL
ALOE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13709-230-01 15 in 1 BOTTLE, DROPPER
2 NDC:13709-230-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part344 2011-08-24


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