Ear Wax Removal Drops Solution/ Drops
FDA Label NDC 57896-339

12 label sections · Submitted to the FDA by Gericare Pharmaceutical Corp · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gericare Pharmaceutical Corp for the product Ear Wax Removal Drops (NDC 57896-339). 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, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of the reach of children, directions, 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% non USP*

*pH differs from USP specifications

Otc - Purpose

Earwax removal aid

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings

Do not use

  • if you are dizzy
  • if you have ear drainage or discharge, ear pain, irritation or rashin the ear. Consult your doctor.
  • if you have an injury or perforation (hole) of the ear drum or after ear surgery, unless directed by a doctor

When Using This Product

avoid contact with the eyes.

Keep Out Of The Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

​FOR USE IN THE EAR ONLY

Remove any hearing aids before use

Adults and children over 12 years and over:

  • Tilt head to the side and place 5 to 10 drops into the ear canal
  • 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 earwax 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: Ask a doctor.

Other Information

  • do not store above 25C (77F)
  • store bottle in outer carton
  • product foams on contact with earwax due to the release of oxygen. There may be an associated "crackling" sound
  • Keep cap on bottle when not in use

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water

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