Ear Wax Removal System description, usages, side effects, indications, overdosage, supplying and lots more!

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Ear Wax Removal System

CVS Pharmacy

  • 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

CVS Pharmacy, Inc. Ear Wax Removal System Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

For use in the ear only

Do not use:

  • •if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; ask a doctor
  • •if you have an injury or perforation (hole) of the eardrum or after ear surgery unless directed by a doctor
  • •for more than 4 days

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

excessive earwax remains after use of this product for 4 consecutive days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Directions

FOR USE IN THE EAR ONLY

  • •adults and children over 12 years of age:
  • •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
  • •when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal
  • •children under 12 years of age: ask a doctor

Other information

  • •store at 20°-25°C (68°-77°F)
  • •protect from heat or direct sunlight
  • •keep cap tightly on bottle when not in use
  • •product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.

Inactive ingredients

acetaminophen, alcohol, butylated hydroxyanisole, edetate disodium, glycerin, propyl gallate, sodium stannate, succinic anhydride

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient in Murine® Ear Wax Removal System

Fast Acting

EARWAX REMOVAL SYSTEM

REMOVAL AID

CARBAMIDE PEROXIDE 6.5%

Complete 2-step system

EARWAX REMOVAL AID

Ear Wax Removal System

CARBAMIDE PEROXIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-561
Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE 6.5 g

Inactive Ingredients

Ingredient Name Strength
ACETAMINOPHEN
ALCOHOL
BUTYLATED HYDROXYANISOLE
EDETATE DISODIUM
GLYCERIN
PROPYL GALLATE
SODIUM STANNATE
SUCCINIC ANHYDRIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE
2 NDC:59779-561-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part344 2005-06-08


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