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Ear System GNP

Medically reviewed on May 4, 2018

Dosage form: kit
Ingredients: Carbamide Peroxide 6.5g in 100mL
Labeler: Amerisource Bergen
NDC Code: 24385-501

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.

EarWax Removal Drops

Drug Facts

Active ingredient                     Purpose

Carbamide Peroxide 6.5%        Softens & removes wax

Uses

For occasional use as an aid 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.
When using this product avoid contact with eyes

Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
In case of accidental ingestion, seek professional or contact a Poison Control Center immediately.

Directions
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 the ear
• use twice daily for up to 4 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

Glyceryn, Oxyquinoline

EAR SYSTEM  GNP
carbamide peroxide 6.50% kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-501
Packaging
#Item CodePackage Description
1NDC:24385-501-071 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
WAX REMOVAL SYSTEM 
carbamide peroxide 6.50% solution/ drops
Product Information
Item Code (Source)NDC:24385-500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (HYDROGEN PEROXIDE) Carbamide Peroxide6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
OXYQUINOLINE SULFATE 
Packaging
#Item CodePackage Description
1NDC:24385-500-0115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart344
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/15/2003
Labeler - Amerisource Bergen (007914906)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIOperations
Product Quest Mfg, LLC927768135manufacture(24385-500, 24385-501), label(24385-500, 24385-501)

 
Amerisource Bergen

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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