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%


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.

carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49794-003
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carbamide peroxide (UNII: 31PZ2VAU81) (carbamide peroxide - UNII:31PZ2VAU81) carbamide peroxide6.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
glycerin (UNII: PDC6A3C0OX)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49794-003-1515 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34408/27/2010
Labeler - Continental Manufacturing Chemist, Inc. (005278007)
NameAddressID/FEIBusiness Operations
Continental Manufacturing Chemist, Inc.005278007manufacture

Revised: 3/2011
Document Id: d39d1621-4d46-4c22-a0ad-dd78fc4313ef
Set id: 50a2a149-d096-4093-b87b-0aaf3eb8e1df
Version: 3
Effective Time: 20110317
Continental Manufacturing Chemist, Inc.