EAR DROPS MAJOR- carbamide peroxide 6.5% liquid 
Major Pharmaceuticals

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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.

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EAR DROPS  MAJOR
carbamide peroxide 6.5% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-6627-351 in 1 CARTON10/10/2019
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 - Major Pharmaceuticals (191427277)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114analysis(0904-6627) , manufacture(0904-6627) , pack(0904-6627) , label(0904-6627)

Revised: 12/2023
Document Id: 0c7d0e65-8c41-66a5-e063-6294a90ab40a
Set id: ad8bce05-6be4-4f6c-9341-bce7c3aa05cf
Version: 6
Effective Time: 20231214
 
Major Pharmaceuticals