Earwax Removal Aid: Package Insert and Label Information
EARWAX REMOVAL AID- carbamide peroxide liquid
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.
Carbamide Peroxide 6.5%
Earwax Removal Aid
For occasional use to soften, loosen and remove excessive earwax.
For External Use Only
Do not use
- In the eye
- for more than 4 days
Ask a doctor before use if you have
- ear drainage or discharge
- pain, irritation or rash in the ear
- had ear surgery
- an injury or perforation (hole) in the ear drum
Stop use and ask a doctor if
Stop use and ask a doctor if excessive earwax remains after use
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
FOR USE IN THE EAR ONLY
Adults and children 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 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 my 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.
Do not use if imprinted seal on cap is broken or missing.
- Store at controlled room temperature 15 to 30C (59 to 86F)
- KEEP IN A DRY PLACE
Principal Display Panel
Principle display panel:
SM Ear Drops Box
| EARWAX REMOVAL AID |
earwax removal aid liquid
|Labeler — McKesson (177667227)|
|Registrant — Continental Manufacturing Chemist, Inc. (005278007)|
Revised: 08/2012 McKesson
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