Drug Facts Carbamide Peroxide Drops Active Ingredients
Carbamide Peroxide 6.5%
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Wax Out Plus (NDC 13709-313). 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 carbamide peroxide drops active ingredients, purpose, uses, warnings, when using this product:, other information, inactive ingredients, directions for reusable ear cleaners, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Carbamide Peroxide 6.5%
Earwax Removal Aid
Use occasionally as an aid to soften, loosen , and remove excessive earwax.
Do not use:
Glycerin, Oxyquinoline
For use in the ear only. Make sure to check physical integrity of the tool prior to use. When usingfor teh first time, begin with the COIL tool. Grasp tool comfortably between thumb, index and middle fingers. Direct toward ear. Gently advance tool toward the earcanal and SPIN tool continuously - slowly advancing into the outer portion of canal. Rotate in one direction per insertion. For additional extraction, try the BRISTLE, SCREW or CLUB tools. DO NOT POKE OR JAB INTO EAR. DO NOT FORCIBLY ADVANCE. NOT FOR DEEP CANAL INSERTION. Each person's requirements vary. Impacted earwax should be removed by a health care professional. Check with your physician.
DISINFECTIONS INSTRUCTIONS:
Clean with soap and warm water followed by immersing eartools in isopropyl rubbing alcohol 70%. Use tool when dry.
SUGGESTED USE:
Intended for EAR HYGIENE: Cleaning of debris, itch relief, exfoliation, water extraction and superficial wax around the ear and outer ear canal. Daily or less frequent use may be beneficial.
Keep out of reach of Children
Do not use:
If you have had an allergic reactionto carbamide peroxide or other ingredients in teh dropper bottle.
If you have ear drainage or discharge, ear pain, ear infections, irritation, rash in the ear, or are dizzy. (Please consult a doctor with concerns).
If you have an injury or perforation (hole) of the eardrum or after ear surgery or mastoid surgery, unless directed by a doctor.
More than a twice a week.
For children under 12 years of age.
If you have tubes in your ears.
* Please review the disclaimer below.