Drugplain

Auralyt 7.8 mg/12mL

Carbamide Peroxide · LIQUID · Menper Distributors, Inc

No Recall History
Plain English

Auralyt is a liquid containing carbamide peroxide at 7.8 mg/12mL, taken topical. Manufactured by Menper Distributors, Inc.

Key Facts

Brand Name
Auralyt
Generic Name
Carbamide Peroxide
NDC Code (Product)
53145-311
Manufacturer
Menper Distributors, Inc
Strength
7.8 mg/12mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M014
Marketing Start
01/01/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

diarrhoea14 reports
chronic kidney disease9 reports
pneumonia9 reports
fatigue8 reports
pyrexia8 reports
abdominal pain7 reports
blood creatinine increased7 reports
haemoglobin decreased7 reports
acute kidney injury6 reports
anxiety6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses 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 soft ruber bulb ear syringe. Children under 12 years of age: consult a doctor.

Warnings

AVOID CONTACT WITH EYES Do not use : if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy, consult a doctor if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor for more than 4 days; if excessive ear wax remains after use of this product, consult a doctor.

Frequently Asked Questions

What is Auralyt used for?

Auralyt contains Carbamide Peroxide. It is a liquid taken topical. Consult your doctor for specific uses.

Is Auralyt a controlled substance?

Auralyt is not classified as a controlled substance by the DEA.

What is the generic name for Auralyt?

The generic name for Auralyt is Carbamide Peroxide. There are 11 other brand versions of Carbamide Peroxide.

What is the NDC code for Auralyt 7.8 mg/12mL?

The NDC (National Drug Code) for Auralyt 7.8 mg/12mL is 53145-311, listed by Menper Distributors, Inc.