Ear Wax Removal Aid: Package Insert and Label Information

EAR WAX REMOVAL AID — carbamide peroxide liquid
Continental Manufacturing Chemist, Inc.

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.

DIRECTIONS: For use in the ear only. For use by 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 4 days, if needed or as directed by a physician. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. For children under 12 years of age, consult a physician. NOTE: When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

WARNINGS: DO NOT USE if you have ear drainage or discharge, ear pain, irritation, or rash in the ear, or if you are dizzy; consult a physician. DO NOT USE if you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a physician. DO NOT USE for more than 4 days; if excessive earwax remains after use of this product, consult a physician. Avoid contact with eyes. If swallowed, get medical help or contact a Poison Control Center right away.

ACTIVE INGREDIENT: Carbamide Peroxide 6.5%

KEEP OUT OF REACH OF CHILDREN

Softens and removes excessive earwax safely and gently.

Inactive Ingredient: anhydrous glycerin

Uses for occasional use as an aid to soften, loosen and remove excessive earwax.

EAR WAX REMOVAL AID
carbamide peroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49794-003
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 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49794-003-15 15 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part344 08/27/2010
Labeler — Continental Manufacturing Chemist, Inc. (005278007)
Establishment
Name Address ID/FEI Operations
Continental Manufacturing Chemist, Inc. 005278007 manufacture

Revised: 03/2011 Continental Manufacturing Chemist, Inc.

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