AURO EAR WAX REMOVER- carbamide peroxide liquid 
Insight Pharmaceuticals LLC

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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AURO®
EAR DROPS
EARWAX REMOVAL AID

Drug Facts

Active ingredient

Carbamide peroxide 6.5% in anhydrous glycerin

Purpose

Earwax removal aid

Uses

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

Warnings

Flammable, keep away from fire or flame.

FOR EAR USE ONLY

Do not use for more than 4 days

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain, irritation or rash in the ear or are dizzy
  • an injury or perforation (hole) of the eardrum
  • had ear surgery

When using this product avoid contact with the eyes

Stop use and ask a doctor if excessive earwax remains after use

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older

Other information

Inactive ingredients

disodium EDTA, disodium laureth sulfosuccinate, isopropyl alcohol, methylparaben, methyl salicylate, propylene glycol, purified water

Questions?

call 1-800-344-7239

Distributed:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 22mL Tube Carton

DOCTOR
RECOMMENDED
INGREDIENT

AURO®
EAR DROPS

CARBAMIDE PEROXIDE 6.5%
in anhydrous glycerin

EARWAX
REMOVAL AID

SAFE ■ FAST ■ EFFECTIVE
when used as directed

SAFETY SEALED
TUBE TIP

0.75 fl oz. (22mL)

PRINCIPAL DISPLAY PANEL - 22mL Tube Carton
AURO EAR WAX REMOVER 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-232
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide peroxide (UNII: 31PZ2VAU81) (Carbamide peroxide - UNII:31PZ2VAU81) Carbamide peroxide1.44 mL  in 22 mL
Inactive Ingredients
Ingredient NameStrength
Edetate Disodium (UNII: 7FLD91C86K)  
Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
Isopropyl Alcohol (UNII: ND2M416302)  
Methylparaben (UNII: A2I8C7HI9T)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-232-241 in 1 BOX
122 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34407/01/2010
Labeler - Insight Pharmaceuticals LLC (176792315)

Revised: 1/2011
Document Id: 017403c5-1be2-46a2-a6eb-63d15265d4ca
Set id: 924e613b-4952-4861-aac7-b8534ea0f305
Version: 2
Effective Time: 20110131
 
Insight Pharmaceuticals LLC