ENT ESSENTIALS EAR WAX REMVOER- carbamide peroxide liquid 
Wisconsin Pharmacal Company

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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Active Ingredient

Carbamide Peroxide 6.5%

Purpose

Earwax removal aid

Uses

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

Warnings

Aska doctor before use if you have

When using this product avoid contact wtih the eyes

Stop use and aks a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

D irections

FOR USE IN THE EAR ONLY Adults and children over 12 years of age:

tilt head sideways
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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe.

Children under 12 years: consult a doctor.

Other informaiton

Inactive ingredients

Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid

Questions or comments? 1-800-635-3696

Label and Carton

ENT ESSENTIALS EAR WAX REMVOER 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-4503
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
TARTARIC ACID (UNII: W4888I119H)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68093-4503-11 in 1 CARTON02/01/2017
122 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/01/2017
Labeler - Wisconsin Pharmacal Company (800873986)
Establishment
NameAddressID/FEIBusiness Operations
Wisconsin Pharmacal Company800873986manufacture(68093-4503)

Revised: 11/2017
Document Id: 5d7d078f-ef8b-8aa7-e053-2a91aa0ae3b1
Set id: 5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1
Version: 1
Effective Time: 20171108
 
Wisconsin Pharmacal Company