Active Ingredient(S)
Carbamide Peroxide 6.5%
Earwax Removal Aid
FDA Label NDC 49348-960
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Earwax Removal Aid (NDC 49348-960). 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 active ingredient(s), purpose, use(s), warning, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Earwax Removal Aid
Use(S)
For occasional use to soften, loosen and remove excessive earwax.
Warning
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.
Directions
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.
Other Information
Do not use if imprinted seal on cap is broken or missing.
Storage
- 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 (Sunmark Ear Drops 1)
Inactive Ingredients
anhydrous Glycerin
* Please review the disclaimer below.
