OTC Medication Information: Ear Wax Removing Drops Carbamide Peroxide

EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE- carbamide peroxide liquid
Cardinal Health

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.

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

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EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE
leader liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-615
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbamide Peroxide (Carbamide Peroxide) Carbamide Peroxide 6.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Aloe Vera Leaf
CHAMAEMELUM NOBILE FLOWER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37205-615-56 1 BOTTLE (BOTTLE) in 1 PACKAGE, COMBINATION contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the PACKAGE, COMBINATION (37205-615-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 12/01/2011
Labeler — Cardinal Health (097537435)

Revised: 01/2012 Cardinal Health

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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