DEBROX: Package Insert and Label Information
DEBROX- carbamide peroxide liquid
Proficient Rx LP
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active ingredient
Carbamide peroxide 6.5% non USP*
*pH differs from USP specifications
Purpose
Earwax removal aid
Uses
for occasional use as an aid to soften, loosen, and remove excessive earwax
Warnings
Ask a doctor before use if you have
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- ear drainage or discharge
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- ear pain
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- irritation or rash in the ear
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- dizziness
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- an injury or perforation (hole) of the eardrum
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- recently had ear surgery
When using this product
avoid contact with the eyes
Stop use and ask a doctor if
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- you need to use for more than four days
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- excessive earwax remains after use of this product
Keep this and all drugs out of the 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:
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- tilt head sideways
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- place 5 to 10 drops into ear
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- tip of applicator should not enter ear canal
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- keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
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- use twice daily for up to four days if needed, or as directed by a doctor
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- 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: consult a doctor
Other information
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- do not store above 25C (77F)
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- store bottle in the outer carton
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- product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
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- keep tip on bottle when not in use
Inactive ingredients
citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water
Questions or comments?
call toll-free 1-866-255-5202 Debrox.com
PRINCIPAL DISPLAY PANEL
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
Debrox® DROPS
Carbamide Peroxide 6.5% Non USP*
Earwax Removal Aid
Kit includes soft rubber bulb ear syringe and drops
½ FL OZ (15mL)
71205-136-15
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| Labeler — Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Proficient Rx LP | 079196022 | RELABEL (71205-136) | |
Revised: 10/2019 Proficient Rx LP
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