EAR WAX REMOVAL DROPS- carbamide peroxide - 6.5% solution/ drops 
GeriCare Pharmaceutical Corp

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.

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Drug Facts

Active ingredient

Carbamide Peroxide, 6.5%

Earwax removal aid

Uses

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

Warnings

Do not use if you have 

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

Other information

Inactive ingredients

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

Principal Display Panel Bottle Label 0.5 FL OZ

Principal Display Panel Bottle Label 1/2 FL OZ

Preferred Plus Pharmacy

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel - Carton label 0.5 FL OZ

Principal Display Panel - Carton label 1/2 FL OZ

Preferred  Plus Pharmacy

Ear wax Remover Drops 

Carbamide Peroxide 6.5%

Ear wax removal aid 

0.5 FL OZ ( 15ml)

EAR WAX REMOVAL DROPS 
carbamide peroxide - 6.5% solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-339
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:57896-339-051 in 1 CARTON05/27/2014
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 finalpart34405/27/2014
Labeler - GeriCare Pharmaceutical Corp (611196254)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(57896-339)

Revised: 12/2017
Document Id: fc3b137e-909a-4170-9a3b-83feaa333cd9
Set id: 239702af-cf93-43ee-b1af-8e53642395c1
Version: 1
Effective Time: 20171228
 
GeriCare Pharmaceutical Corp