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Ear Wax Removal by Starkey Hearing Technologies

Medically reviewed on December 11, 2017

Dosage form: liquid
Ingredients: Carbamide peroxide 6.5g in 100mL
Labeler: Starkey Hearing Technologies
NDC Code: 70903-200

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.

Ear Wax Removal Kit Carton

Drug Facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Ear wax removal product

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax

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 ear wax 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 or 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 ear wax due to release of oxygen. There may be an associated "crackling" sound.

Inactive ingredients

Glycerin, propylene glycol, peppermint flavor, citric acid, sodium lauroyl sarcosinate

Tamper Evident. Do not use if neckband on bottle is broken or missing.

Questions or comments?

877-373-4034

Principal Display Panel – Carton Label

Starkey®

Hearing Technologies

Ear Wax
Removal Kit

Carbamide peroxide
ear wax removal aid

Safe and gentle

Fast-acting formula

Easily cleanses ear
with microfoam action

Safe for
all ages

AUDIOLOGIST
RECOMMENDED

.5 FL OZ (15mL) & SYRINGE

EAR WAX REMOVAL 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70903-200
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide peroxide (Hydrogen Peroxide) Carbamide peroxide6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Propylene glycol 
Peppermint 
Citric Acid Monohydrate 
Sodium lauroyl sarcosinate 
Packaging
#Item CodePackage Description
1NDC:70903-200-161 BOTTLE, DROPPER in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/01/2016
Labeler - Starkey Hearing Technologies (055461479)

 
Starkey Hearing Technologies

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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