EAR WAX REMOVAL DROPS EQUATE- carbamide peroxide - 6.5% solution/ drops 
WALMART STORES INC

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%

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

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

Equate NDC 49035-862-02

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml) 

Principal Display Panel Bottle Label 0.5 FL OZ

Principal Display Panel - Carton label 0.5 FL OZ

Equate       NDC 49035-862-02

Ear wax Remover Drops 

Carbamide Peroxide 6.5%

Ear wax removal aid 

0.5 FL OZ ( 15ml)

Principal Display Panel - Carton label 0.5 FLOZ

Principal Display Panel - Carton label 0.5 FLOZ

Principal Display Panel - Carton label KIT 0.5 FL OZ

Equate NDC 49035-862-02

Ear wax Remover Kit

Carbamide Peroxide 6.5%

Ear wax removal aid

0.5 FL OZ ( 15ml)

image description

EAR WAX REMOVAL DROPS  EQUATE
carbamide peroxide - 6.5% solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-862
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:49035-862-021 in 1 CARTON03/01/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:49035-862-011 in 1 KIT03/01/2019
215 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 finalpart34403/01/2019
Labeler - WALMART STORES INC (051957769)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(49035-862)

Revised: 11/2018
Document Id: 28736548-09b6-4dcb-acdf-00ae56a6b3f4
Set id: 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d
Version: 1
Effective Time: 20181107
 
WALMART STORES INC