Auro Ear Wax Remover description, usages, side effects, indications, overdosage, supplying and lots more!

Auro Ear Wax Remover

Insight Pharmaceuticals LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
AURO EAR DROPS EARWAX REMOVAL AID

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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)

PRINCIPAL DISPLAY PANEL - 22mL Tube Carton

Auro Ear Wax Remover

Carbamide peroxide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-232
Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE 1.44 mL

Inactive Ingredients

Ingredient Name Strength
EDETATE DISODIUM
disodium laureth sulfosuccinate
ISOPROPYL ALCOHOL
METHYLPARABEN
methyl salicylate
propylene glycol
water

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 22 in 1 TUBE
2 NDC:63736-232-24 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part344 2010-07-01


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Be sure to consult your doctor before taking any medication!
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