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Ear Wax Removing Drops Carbamide Peroxide

Dosage form: liquid
Ingredients: Carbamide Peroxide 6.5g in 100mL
Labeler: Cardinal Health
NDC Code: 37205-615

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

Carbamide Peroxide 6.5%

Purpose

Carbamide Peroxide 6.5%

Uses

For occasional use as an aid to 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.  For more than four consecutive days.

When using this product: avoid contact with the eyes.

Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Directions

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 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 flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age:  consult a doctor.

Inactive ingredients

Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil

Ear Wax Cleansing Kit

Step 1 Ear Wax Removing Drops

Step 2 Ear Cleansing Spray


EAR WAX REMOVING DROPS  CARBAMIDE PEROXIDE
leader liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-615
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (Carbamide Peroxide) Carbamide Peroxide6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf 
CHAMAEMELUM NOBILE FLOWER OIL  
Packaging
#Item CodePackage Description
1NDC:37205-615-561 BOTTLE (BOTTLE) in 1 PACKAGE, COMBINATION
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34412/01/2011
Labeler - Cardinal Health (097537435)

Revised: 01/2012
 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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