Otc - Purpose
Active Ingredient Purpose
Carbamide peroxide 6.5%....................Earwax removal aid
Doloear Liquid
FDA Label NDC 55758-506
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Doloear (NDC 55758-506). 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 otc - purpose, uses, warnings, when using this product, stop use and ask your doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For occasional use as an aid to loosen and remove excessive earwax.
Warnings
Ask a doctor before use if you have
- ear drainage or discharge
- ear pain
- irritation or rash in the ear
- dizziness
- an injury or perforation (hole) of the ear drum
- recently had ear surgery
When Using This Product
avoid contact with the eyes.
Stop Use And Ask Your Doctor If
- you need to use for more than 4 days
- excessive earwax remains after use of this product
Directions
- FOR USE IN THE EAR ONLY
- adults and children over 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 may 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
- Store in a cool dry place
- do not use if clear seal over dropper is torn, broken, or missing
Inactive Ingredients
glycerin, water
Questions Or Comments?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Dist. By/ Por:
PHARMADEL LLC
New Castle, DE 19720
+1-866-359-3478
www.pharmadel.com
* Please review the disclaimer below.
