EAR DROPS EARWAX REMOVAL AID- carbamide peroxide liquid 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy)

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.

----------

Drug Facts

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 do not get into eyes

Keep out of reach of children

In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

Directions

FOR USE IN THE EAR ONLY

Other information

Inactive ingredients

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

image of label

image of carton

EAR DROPS  EARWAX REMOVAL AID
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-955
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:24385-955-011 in 1 CARTON
1NDC:24385-955-0215 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34401/01/2012
Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) (007914906)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
AmerisourceBergen Drug Corporation007914906label(24385-955)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432manufacture(24385-955)

Revised: 6/2013
Document Id: e9d8b71c-e35f-44fa-9542-d4d2278c9a7f
Set id: 33442c7e-46dc-4126-abb9-492f94bce5c3
Version: 1
Effective Time: 20130628
 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy)