FDA Label for Ent Essentials Ear Wax Remvoer
View Indications, Usage & Precautions
Ent Essentials Ear Wax Remvoer Product Label
The following document was submitted to the FDA by the labeler of this product Wisconsin Pharmacal Company. 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.
Otc - Active Ingredient
Active Ingredient
Carbamide Peroxide 6.5%
Otc - Purpose
Purpose
Earwax removal aid
Indications & Usage
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Warnings
Warnings
Otc - Ask Doctor
Aska doctor before use if you have
- ear drainage or discharge
- ear pain
- irritation or rash in the ear
- dizziness
- an injury or perforation (hole) of the eardrum
- recently had ear surgery
Otc - When Using
When using this product avoid contact wtih the eyes
Otc - Stop Use
Stop use and aks a doctor if
- you need to use for more than four days
- excessive earwax remains after use of this product
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
D irections
FOR USE IN THE EAR ONLY Adults and children over 12 years of age:
tilt head sideways
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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe.
Children under 12 years: consult a doctor.
Other Safety Information
Other informaiton
- store bottle in teh outer carton
- product foams on contact with earwax due to the release of oxygen. Theremay be an associated "crackling" sound
- keep cap on bottle when not in use
Inactive Ingredient
Inactive ingredients
Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid
Otc - Questions
Questions or comments? 1-800-635-3696
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