Debrox Swimmers Ear Liquid
FDA Label NDC 63029-323

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Debrox Swimmers Ear (NDC 63029-323). 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 purpose, use, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Isopropyl alcohol 95% in an anhydrous glycerin 5% base ....Ear drying aid

Use

dries water in the ears and relieves water-clogged ears after

  • swimming
  • showering
  • bathing
  • washing the hair

Warnings

Flammable: Keep away from fire or flame

Do Not Use

in the eyes

Ask A Doctor Before Use If You Have

• ear drainage or discharge

• ear pain, irritation or rash in the ear • dizziness

• recently had ear surgery

Stop Use And Ask A Doctor If

irritation (too much burning) or pain occurs

Keep Out Of Reach Of Children.

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

Directions

  • unscrew cap from bottle
  • remove foil safety seal from bottle
  • affix applicator cap to bottle
  • remove red applicator cap tip
  • apply 4 to 5 drops in each affected ear

Other Information

  • recap bottle after each use
  • keep away from head or direct sunlight
  • store at room temperature 15-25°C (59-77°F)
  • do not use if foil seal imprinted with “SEALED FOR YOUR PROTECTION” under cap is broken or missing
  • keep carton for full drug facts

Inactive

Glycerin

Questions?

1-800-344-7239 debrox.com

Principal Display Panel

Debrox ® Swimmer’s Ear

Isopropyl alcohol 95%

Ear Drying Drops

1 FL OZ (30 mL)

Principal Display Paneldebrox ® Swimmer’s Earisopropyl Alcohol 95%ear Drying Drops1 Fl Oz (30 mL) (Debrox Swimmers Ear 01)

Principal Display Paneldebrox ® Swimmer’s Earisopropyl Alcohol 95%ear Drying Drops1 Fl Oz (30 mL) (Debrox Swimmers Ear 01)

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