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  5. Label Information: Ear Wax Removal Drops Preferred Plus Pharmacy

FDA Label for Ear Wax Removal Drops Preferred Plus Pharmacy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. KEEP OUT OF THE REACH OF CHILDREN
    7. DIRECTIONS FOR USE IN THE EAR ONLY
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. PRINCIPAL DISPLAY PANEL BOTTLE LABEL 0.5 FL OZ
    11. PRINCIPAL DISPLAY PANEL - CARTON LABEL 0.5 FL OZ

Ear Wax Removal Drops Preferred Plus Pharmacy Product Label

The following document was submitted to the FDA by the labeler of this product Kinray. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.