Label: EAR WAX REMOVAL AID- carbamide peroxide liquid
Contains inactivated NDC Code(s)
NDC Code(s): 49794-003-15
- Packager: Continental Manufacturing Chemist, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated March 17, 2011
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DOSAGE & ADMINISTRATION
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
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
INGREDIENTS AND APPEARANCE
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) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength carbamide peroxide (UNII: 31PZ2VAU81) (carbamide peroxide - UNII:31PZ2VAU81) carbamide peroxide 6.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49794-003-15 15 mL in 1 BOTTLE, DROPPER 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 Business Operations Continental Manufacturing Chemist, Inc. 005278007 manufacture