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Ear Wax Remover by Major Pharmaceuticals

Medically reviewed on March 12, 2018

Dosage form: liquid
Ingredients: CARBAMIDE PEROXIDE 65mg in 1mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-6004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

drug facts

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

Principal Display Panel

NDC 0904-6004-35

EAR WAX REMOVER
WITH IRRIGATOR
Earwax Removal Aid
(carbamide peroxide 6.5%)

Distributed by:

MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150  USA

Questions?

 Adverse Drug Event Call toll free: (800) 616-2471

EAR WAX REMOVER 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6004
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
SODIUM LAURYL SULFATE 
SODIUM CITRATE 
GLYCERYL 1-DIACETYLTARTARATE 2,3-STEARATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6004-351 BOTTLE, DISPENSING (1 BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34405/27/2009
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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