Auro Ear Wax Remover

carbamide peroxide

Dosage Form: ear drops
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 Carton

BONUS

50% MORE

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 Type HUMAN OTC DRUG NDC Product Code (Source) 63736-232 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbamide peroxide (Carbamide peroxide) Carbamide peroxide 1.44 mL  in 22 mL

Inactive Ingredients Ingredient Name Strength Edetate Disodium   Disodium Laureth Sulfosuccinate   Isopropyl Alcohol   Methylparaben   Methyl Salicylate   Propylene Glycol   Water

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63736-232-24 1 TUBE In 1 BOX contains a TUBE 1 22 mL In 1 TUBE This package is contained within the BOX (63736-232-24)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part344	07/01/2010

Labeler - Insight Pharmaceuticals LLC (176792315)

Revised: 09/2010Insight Pharmaceuticals LLC

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