FDA Label for Walgreens Ear Wax Remover

View Indications, Usage & Precautions

Walgreens Ear Wax Remover Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens Company. 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



Ear Wax Removal Aid


Uses



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


Warnings



Ask a Doctor before use if you have

  • eardrainage, discharge, ear pain,irritation
  • rash in the ear,or are dizzy
  • injury or perforation (hole) of the ear drum
  • Recently had ear surgery

Stop Use And Ask A Doctor If



  • you need to use for more than 4 days
  • execessive ear wax remain after use of this product

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.


Inactive Ingredients



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


Other Information



Protect from heat and direct sunlight
product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
Keep cap on bottle when not in use.
Lot No. and EXP date: see label, bottom container or box.


Principal Display Panel Bottle Label 0.5 Fl Oz



Walgreens Ear Wax RemoverĀ  NDC 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)


Principal Display Panel Carton Label 0.5 Fl Oz



Walgreens Ear Wax Remover NDC 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)


Principal Display Panel Kit Label 0.5 Fl Oz



Walgreens Ear Wax Remover KitĀ  NDC 0363-2068-25

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)


* Please review the disclaimer below.