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Ear Wax Removal Drops Preferred Plus Pharmacy

Medically reviewed on Nov 27, 2017

Dosage form: solution/ drops
Ingredients: CARBAMIDE PEROXIDE 65mg in 1mL
Labeler: Kinray
NDC Code: 61715-171

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.

Drug Facts

Active ingredient

Carbamide Peroxide, 6.5%

Purpose

Earwax removal aid

Uses

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

Warnings

Do not use if you have 

  • eardrainage, discharge, ear pain,irritation
  • rashin the ear,or are dizzy
  • injuryor perforation (hole) of the ear drum or after ear surgery

When using this product 
  • do not use for more than four days
  • avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
  • if excessive earwax remains after the use of this product, consult a doctor

Keep out of the 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 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 earwax 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:  consult a doctor.

Other information
  • Protect from heat and direct sunlight 
  • Keep cap on bottle when not in use.
  • Lot No. and EXP date:  see label, bottom container or box.

Inactive ingredients

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Principal Display Panel Bottle Label 0.5 FL OZ

Preferred Plus Pharmacy

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel - Carton label 0.5 FL OZ

Preferred  Plus Pharmacy

Ear wax Remover Drops 

Carbamide Peroxide 6.5%

Ear wax removal aid 

0.5 FL OZ ( 15ml)

EAR WAX REMOVAL DROPS  PREFERRED PLUS PHARMACY
carbamide peroxide - 6.5% solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-171
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
ANHYDROUS CITRIC ACID 
PROPYLENE GLYCOL 
SODIUM CITRATE 
SODIUM LAURYL SULFATE 
TARTARIC ACID 
Packaging
#Item CodePackage Description
1NDC:61715-171-741 BOTTLE, DROPPER in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34406/09/2014
Labeler - Kinray (012574513)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIOperations
Sheffield Pharmaceuticals LLC151177797manufacture(61715-171)

 
Kinray

Further information

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

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