FDA Label for Ear System Gnp
View Indications, Usage & Precautions
Ear System Gnp Product Label
The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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.
Active Ingredient Purpose
Carbamide Peroxide 6.5% Softens & removes wax
Uses
For occasional use as an aid soften, loosen, and remove excessive ear wax
Warnings
Do not use
• If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor.
• If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor.
When using this product avoid contact with eyes
Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days
Directionsdirections For Use In The Ear Only.
Adults and children over 12 years of age:
• tilt head sideways and 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 4 days if needed, or as directed by a doctor
• any wax 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 of age: consult a doctor.
Inactive Ingredients
Glyceryn, Oxyquinoline
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