Purpose
Isopropyl alcohol 95% in an anhydrous glycerin 5% base ....Ear drying aid
Debrox Kids Liquid
FDA Label NDC 63029-325
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 Kids (NDC 63029-325). 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, ask a doctor before use if you have, keep out of reach of children., directions, other information, inactive, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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 heat or direct sunlight
- store at room temperature 15-25°C (59-77°F)
Inactive
Glycerin
Questions?
1-800-344-7239 debrox.com
Principal Display Panel
Debrox ® Kids
Isopropyl alcohol 95%
Ear Drying Drops
1 FL OZ (30 mL)
Principal Display Paneldebrox ® Kidsisopropyl Alcohol 95%ear Drying Drops1 Fl Oz (30 mL) (Debrox Kids Ear Discomfort Relief 63029 325 01)
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