CLEARCANAL EAR WAX SOFTERNER DROPS- carbamide peroxide solution/ drops

ClearCanal Ear Wax Softerner Drops by

Drug Labeling and Warnings

ClearCanal Ear Wax Softerner Drops by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
  

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Inactive Ingredients: Glycerin, Oxyquinoline, Aloe Barbadensis, Chamomile

PURPOSE

Softens ear wax. Ear wax removal drops

ASK DOCTOR

Children under 12 years of age: consult a doctor.

KEEP OUT OF REACH OF CHILDREN

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

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

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

WHEN USING

When using this product:

    * Avoid contact with the eyes

DESCRIPTION

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).

DOSAGE & ADMINISTRATION

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

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEARCANAL EAR WAX SOFTERNER DROPS 
carbamide peroxide solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-230
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
OXYQUINOLINE (UNII: 5UTX5635HP)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-230-01	1 in 1 BOX	01/02/2012
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part344	08/24/2011

Labeler - NeilMed Pharmaceuticals, Inc. (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals, Inc.		799295915	manufacture(13709-230)