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  5. Label Information: Ear Drops Earwax Removal Aid

FDA Label for Ear Drops Earwax Removal Aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. STOP USE AND ASK A DOCTOR IF
    6. KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS

Ear Drops Earwax Removal Aid Product Label

The following document was submitted to the FDA by the labeler of this product Amerisourcebergen Drug Corporation (good Neighbor Pharmacy). 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




Stop Use And Ask A Doctor If



  • you need to use of r more than 4 days
  • excessive ear wax remains after use of this product

Keep Out Of Reach Of Children



In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately


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 ear syringe.
  • Children under 12 years:  consult a doctor.

Other Information



  • Avoid exposing bottle to excessive heat and direct sunlight.
  • Product foams on contact with earwax due to release of oxygen.  There may be an associated crackling.
  • Keep cap on bottle when not in use.
  • Lot no. and exp. date:  see label, bottom container or box.

Inactive Ingredients



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


* Please review the disclaimer below.