Drugplain

Ear Drops Major 6.5 g/100mL

Carbamide Peroxide 6.5% · LIQUID · A-S Medication Solutions

No Recall History
Plain English

Ear Drops Major is a liquid containing carbamide peroxide 6.5% at 6.5 g/100mL, taken auricular (otic). Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
Ear Drops Major
Generic Name
Carbamide Peroxide 6.5%
NDC Code (Product)
50090-5273
Manufacturer
A-S Medication Solutions
Strength
6.5 g/100mL
Dosage Form
LIQUID
Route
AURICULAR (OTIC)
Marketing Status
Application #
M014
Marketing Start
10/10/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea4 reports
drug ineffective3 reports
pain3 reports
asthenia2 reports
blood glucose increased2 reports
drug dose omission2 reports
erythema2 reports
eye irritation2 reports
fatigue2 reports
malaise2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

For occasional use as an aid to soften. loosen and remove excessive earwax.

Dosage & Administration

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.

Warnings

Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with eyes Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is Ear Drops Major used for?

Ear Drops Major contains Carbamide Peroxide 6.5%. It is a liquid taken auricular (otic). Consult your doctor for specific uses.

Is Ear Drops Major a controlled substance?

Ear Drops Major is not classified as a controlled substance by the DEA.

What is the generic name for Ear Drops Major?

The generic name for Ear Drops Major is Carbamide Peroxide 6.5%. There are 10 other brand versions of Carbamide Peroxide 6.5%.

What is the NDC code for Ear Drops Major 6.5 g/100mL?

The NDC (National Drug Code) for Ear Drops Major 6.5 g/100mL is 50090-5273, listed by A-S Medication Solutions.

Product NDC

50090-5273

Package NDC

50090-5273-0

Other Ear Drops Major Dosages

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)