FDA Label for Quality Choice Ear Relief Drops

View Indications, Usage & Precautions

Quality Choice Ear Relief Drops Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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 Ingredients



Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X


Purpose



sensitivity to drafts, soothing fullness, sensitivity to cold itchingness, sensitivity to water


Uses



Helps relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.


Do Not Use



  • in the eyes.
  • Initial exacerbation may occur.

Ask A Doctor Before Use If You Have:



  • ear drainage or discharge
  • pain, irritation, or rash in the ear
  • had ear surgery
  • dizziness

Stop Use And Ask A Doctor If:



  • irritation (too much burning) or pain occurs
  • symptoms persist for more than 48 hours

If Pregnant Or Breast Feeding,



ask a health professional before use.


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.

  • Remove tamper-evident seal from neck of bottle.
  • Twist cap off bottle.
  • Tilt head sideways.
  • Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).
  • Keep drops in ear by keeping head tilted or placing cotton in ear.
  • Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.
  • Children under 12 years of age consult a doctor.

Other Information



  • Active ingredients are manufactured according to homeopathic principles.
  • Do not use if tamper-evident safety seal is missing or broken.

Inactive Ingredient



Vegetable glycerin


Questions?



248-449-9300


Package Labeling:




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