Auralyt Liquid
FDA Label NDC 53145-311

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc for the product Auralyt (NDC 53145-311). 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, purpose, uses, avoid contact with eyes, otc - keep out of reach of children, if pregnate or breast-feeding, directions for use in the ear only., other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Carbamide Peroxide 6.5%...........Earwax removal aid

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, loosen and remove excessive earwax

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.

Otc - Keep Out Of Reach Of Children

keep out of reach of children.

If Pregnate Or Breast-Feeding

ask a health professional before use.

In case of accidental indegestion, get medical help or contact a Poison Control Center right away.

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.

Other Information

Store this product between 15° to 30° C (59°-86° F)
Tamper-Evident Feature: Do not use this product if imprinted safety seal over bottle cap is torn, broken, or missing

Inactive Ingredients

Cajeput oil, camphor, eucalyptus oil, glycerin, menthol, methlyparaben, phosphoric acid, polysorbate 20, propylene glycol, sodium stannate, water

Questions Or Comments?

1-800-560-5223 M-F from 9 AM to 4 PM  Eastern.

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Auralyt (Auralyt)

Auralyt (Auralyt)

Auralyt (Auralyt)

Auralyt (Auralyt)

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