FDA Label for Ear Wax Remover
View Indications, Usage & Precautions
Ear Wax Remover Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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
Active ingredient Purpose
Carbamide Peroxide 6.5%..........................Earwax Removal Aid
Uses
Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.
Indications And Usage
Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
Warnings
Warnings
Ask a 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 ear drum
- recently had ear surgery
Stop use and ask a doctor if
- you need to use for more than four days
- excessive wax remains after use of this product
When using this product - avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult your doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
Directions
FOR USE IN THE EAR ONLY
Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.
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 ear syringe.
- when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal
Children under 12 years of age: consult a doctor.
Other information
- avoid exposing the bottle to excessive heat and direct sunlight
- keep cap on bottle when not in use
- lot no. & exp date: see label, bottom of container or box
- retain carton for future reference on full labeling
- Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound
- Note: Oversize packaging for ease in reading label information. Contains one bottle.
- Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredients
Inactive ingredients
anhydrous glycerin, citric acid, propylene glycol, sodium lauryl sulfate, sodium citrate, tartaric acid
Questions?
Adverse Drug Event Call toll free: (800) 616-2471
Principal Display Panel
NDC 63187-187-15
EAR WAX REMOVER
WITH IRRIGATOR
Earwax Removal Aid
(carbamide peroxide 6.5%)
Distributed by:
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA
Relabeled By:
Proficient Rx LP
Thousand Oaks, CA 91320
* Please review the disclaimer below.