FDA Label for Healthmart Earwax Removal Kit Ear Wax Drops And Bulb

View Indications, Usage & Precautions

Healthmart Earwax Removal Kit Ear Wax Drops And Bulb Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson Corp Via Strategic Sourcing Services Llc. 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%

Carbamide peroxide 6.5%


Purpose



Ear wax removal aid

Ear wax removal aid


Uses



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

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


Warnings



For use in the ear only

For use in the ear only


Ask A Doctor Before Use If You Have



• ear drainage or discharge • ear pain • irritation, or rash in the ear • dizziness • an injury or perforation (hole) of the ear drum • recently had ear surgery

• ear drainage or discharge • ear pain • irritation, or rash in the ear • dizziness • an injury or perforation (hole) of the ear drum • recently had ear surgery


When Using This Product



• avoid contact with the eyes

  • avoid contact with the eyes

Stop Use And Ask A Doctor If



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

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

Keep Out Of Reach Of Children.



If swallowed get medical help or contact a Poison Control Center (800-222-1222) right away.

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) 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 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

    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
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound
  • Do not use if tamper-evident safety seal is broken or missing
    • Avoid exposing bottle to excessive heat and direct sunlight 
    • Store bottle in the outer carton
    • Do not store above 25°C (77°F)
    • Keep cap on bottle when not in use
    • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound.
    • Do not use if tamper-evident safety seal is broken or missing

Inactive Ingredients



anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water


Questions?



1-800-328-5890

1-800-328-5890 Weekdays 8:30-5:00 CST


Inactive Ingredients



anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water


Package Labeling:Kit




Package Labeling:62011-0483-1




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