EAR DROPS MAJOR- carbamide peroxide 6.5% liquid 
A-S Medication Solutions

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Ear Drops Major

Carbamide Peroxide 6.5%

Earwax Removal Aid

For occasional use as an aid to soften. loosen and remove excessive earwax.

Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

When using this product avoid contact with eyes

Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product

Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away

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.

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

If swallowed, get medical help or contact a Poison Control Center right away.

Carbamide Peroxide 6.5%

Label Image
EAR DROPS  MAJOR
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5273(NDC:0904-6627)
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM STANNATE (UNII: NJ7C1V83KG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-5273-01 in 1 CARTON10/20/2020
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01410/10/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-5273)

Revised: 1/2024
Document Id: bac0c4d3-f01c-4ade-a739-51480e272328
Set id: eb7df1cc-50db-479a-bc1c-dfd7004dd35b
Version: 6
Effective Time: 20240108
 
A-S Medication Solutions