Auro Ear Wax Remover

Dosage form: liquid
Ingredients: Carbamide peroxide 1.44mL in 22mL
Labeler: Insight Pharmaceuticals LLC
NDC Code: 63736-232

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.

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

  • tilt head sideways and 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 4 days if needed or as directed by a doctor
  • any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
  • children under 12 years of age consult a doctor

Other information
  • recap tube after each use
  • store at room temperature
  • keep carton for full drug facts

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)

AURO EAR WAX REMOVER 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-232
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide peroxide (Carbamide peroxide) Carbamide peroxide1.44 mL  in 22 mL
Inactive Ingredients
Ingredient NameStrength
Edetate Disodium 
Disodium Laureth Sulfosuccinate 
Isopropyl Alcohol 
Methylparaben 
Methyl Salicylate 
Propylene Glycol 
Water 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-232-241 TUBE (TUBE) 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: 01/2011
 
Insight Pharmaceuticals LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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