FDA Label for Earwax Removal Kit
View Indications, Usage & Precautions
Earwax Removal Kit Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Carbamide Peroxide 6.5%
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:
Inactive Ingredients
anhydrous Glycerin
Questions Or Comments?
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