Earwax Removal Aid description, usages, side effects, indications, overdosage, supplying and lots more!

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Earwax Removal Aid

Preferred Pharmaceuticals, Inc.

drug facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient



Active ingredient                                 Purpose

Carbamide Peroxide 6.5%..........................Earwax Removal Aid


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.

Earwax Removal Aid 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

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.

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
- 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

Principal Display Panel

NDC 68788-0225-1

EAR DROPS
Earwax Removal Aid
(carbamide peroxide 6.5%)

Distributed by:

MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150  USA

Earwax Removal Aid

CARBAMIDE PEROXIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-0225(NDC:0904-6316)
Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE 65 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
propylene glycol
CITRIC ACID MONOHYDRATE
SODIUM LAURYL SULFATE
SODIUM CITRATE
GLYCERYL 1-DIACETYLTARTRATE 2,3-DISTEARATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DISPENSING
2 NDC:68788-0225-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part344 2011-05-23


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Be sure to consult your doctor before taking any medication!
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