Drug Facts
Active Ingredients
Carbamide Peroxide 6.5%
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Neilmed Clear Canal Earwax Removal Kit (NDC 13709-314). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, ! warnings, when using this product:, stop use and ask a doctor if:, keep this and all drugs out of the reach of children, directions for use in the ear only, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients
Carbamide Peroxide 6.5%
Earwax Softener
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Avoid using the product and ask a doctor before use if you have :
To prevent contamination, do not share this product with others.
Avoid contact with the eyes. If accidental contact occurs, flush eyes with water and consult a doctor.
Children under 12 years should not use this product.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Adults and children over 12 years of age:
Recommended storage conditions:
Glycerin, Oxyquinoline
1 can saline spray 75ml (2.53 fl oz), 1 bottle of ear drops 15ml (0.5 fl oz), 1 drainage collection cup, 2 ear plugs, 1 waxout tool and 1 soft silicone ear syringe. Colors of parts may vary.
This product is intended for use on adults and children over 12 years of age. Consult your physician for use on children under 12.
Tilt head sideways and place 10 drops of ClearCanal Carbamide peroxide into each ear canal by squeezing the plastic dropper bottle provided with this system. The tip of bottle should not enter ear canal.
Keep drops in ear for 10 minutes by head tilted or placing enclosed ear plugs in ears. It is normal to feel warmth in ear due to carbamide peroxide. Remove ear plugs. Attach the special drainage collection cup to the canister to avoid the rinse solution dripping out of your ear. Flush ears with the NeilMed ClearCanal specially designed actuator nozzle for 10 seconds or as desired to achieve adequate flushing. Gently tilt head side to side to drain out residual liquid and dry ears with a clean dry towel wrapped on a finger.
* Please review the disclaimer below.