FDA Label for Clearcanal Ear Wax Softerner Drops
View Indications, Usage & Precautions
Clearcanal Ear Wax Softerner Drops Product Label
The following document was submitted to the FDA by the labeler of this product Neilmed Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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
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.
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
Otc - Purpose
Softens ear wax. Ear wax removal drops
Otc - Ask Doctor
Children under 12 years of age: consult a doctor.
Otc - 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.
Otc - 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
Otc - Stop Use
Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days
Otc - 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.
Package Label.Principal Display Panel
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