FDA Label for Ear Wax Removal Aid Drops
View Indications, Usage & Precautions
Ear Wax Removal Aid Drops Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. 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.
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Drug Facts
Active Ingredient
Carbamide peroxide 6.5%
Purpose
Earwax removal aid
Uses
For occasional use as an aid to soften, loosen and remove excessive ear wax
Ask A Doctor Before Use
• if you have ear drainage or discharge• ear pain• irritation or rash in the ear• dizziness• an injury or perforation (hole) of the eardrum• recently had ear surgery
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
• you need to use for more than four days• excessive ear wax remains after use this product
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
FOR USE IN THE EAR ONLY.
• Adults and children over 12 years of age:• tilt head sideways• place 5 to 10 drops into ear canal.• tip of applicator should not enter ear canal.• keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.• Use twice daily for up to 4 days if needed, or as directed by a doctor.• Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
Children under 12 years of age: consult a doctor.
Other Information
• Store at room temperature• Avoid exposing bottle to excessive heat and direct sunlight• Store bottle in the outer carton• Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.• Keep cap on bottle when not in use
Inactive Ingredients
adipic acid, glycerin, polysorbate 80.
Principal Display Panel
NDC 11673-793-15
*Compare to the active ingredient in Debrox® Drops
Ear Wax Removal Aid Drops
Carbamide Peroxide 6.5%
Ear Wax Removal Aid
Safe & Gentle
Microfoam Cleansing Action
Easy to use Instructions
NET WT 0.5 FL OZ (15 mL)
TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN
Dist. By Target Corp.
Mpls, MN 55403
TM & ©2019
*This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox® Drops.
* Please review the disclaimer below.