FDA Label for Debrox Swimmers Ear
View Indications, Usage & Precautions
Debrox Swimmers Ear Product Label
The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
* Please review the disclaimer below.