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Earwax Removal Aid by Apothecary Products, LLC

Medically reviewed on May 24, 2018

Dosage form: liquid
Ingredients: CARBAMIDE PEROXIDE 6.5mg in 100mL
Labeler: Apothecary Products, LLC
NDC Code: 49762-453

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.

Earwax Removal Aid

Active ingredient(s)

 Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid

Use(s)

 For occasional use to soften, loosen and remove excessive earwax.

Warnings

Warning

 For External Use Only

Do not use
  •  In the eye
  • for more than 4 days

Ask a doctor before use if you have
  • ear drainage or discharge
  • pain, irritation or rash in the ear
  • had ear surgery
  • an injury or perforation (hole) in the ear drum

Stop use and ask a doctor if

 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

 FOR USE IN THE EAR ONLY

Adults and children 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 my 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

 Do not use if imprinted seal on cap is broken or missing.

Storage
  •  Store at controlled room temperature 15 to 30C (59 to 86F)
  • KEEP IN A DRY PLACE

Principal Display Panel

 Principle display panel:

Flents Earwax Removal Aid Box

Inactive Ingredients

 anhydrous Glycerin

EARWAX REMOVAL AID 
earwax removal aid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49762-453
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE6.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN120.0 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:49762-453-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34408/31/2010
Labeler - Apothecary Products, LLC (092312735)
Registrant - Continental Manufacturing Chemist, Inc. (005278007)

 
Apothecary Products, LLC

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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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