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  5. Label Information: Hal-hen Earwax Removal System

FDA Label for Hal-hen Earwax Removal System

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PACKAGE LABELING: KIT
    15. PACKAGE LABELING:

Hal-hen Earwax Removal System Product Label

The following document was submitted to the FDA by the labeler of this product Warner Tech-care Products, 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.

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 earwax


Warnings



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

When Using This Product



  • avoid contact with the eyes

Stop Use And Ask A Doctor If



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

Keep Out Of Reach Of Children.



If swallowed get medical help or contact a Poison Control Center right away.


Directions



FOR USE IN THE EAR ONLY

Adult 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 earwax due to release of oxygen. There may be an associated cracking 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?



1-800-242-5436


Package Labeling: Kit



Kit - Kit

Kit - Kit


Package Labeling:



Label - Label

Label - Label


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