EAR WAX REMOVAL DROPS- carbamide peroxide - 6.5% solution/ drops 
Sheffield Pharmaceuticals LLC

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Active Ingredient

Carbamide Peroxide 6.5%

Purpose 

Earwax Removal Aid 

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings

Ask a Doctor before use if you have

Stop Use and Ask a Doctor if 

When Using this Product 

Keep out of the reach of children

If 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:

Children under 12 years: consult a doctor.

Other Information 

Inactive Ingredients 

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Principal Display Panel -Bottle Label 

Sheffield       

Earwax Removal Aid Drops 

Carbamide Peroxide 6.5%

NET 0.5 FLOZ (15 ml )

543480-Sheffield-Ear-Wax-Drops_BOX

7004681B-Sheffield-Ear-Drops-LBL

EAR WAX REMOVAL DROPS 
carbamide peroxide - 6.5% solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TARTARIC ACID (UNII: W4888I119H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-143-511 in 1 CARTON02/02/2017
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01402/02/2017
Labeler - Sheffield Pharmaceuticals LLC (151177797)

Revised: 12/2022
Document Id: 184c7110-33c6-4b58-bc79-451870131f3a
Set id: aad7e2cd-cb28-423c-a441-eabe6516d40f
Version: 1
Effective Time: 20221206
 
Sheffield Pharmaceuticals LLC