Premier Value Ear Relief Ear Drops Solution/ Drops
FDA Label NDC 68016-377

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Ear Relief Ear Drops (NDC 68016-377). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, ask a doctor before use if you have:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

sensitivity to dreafts, soothing

fullness, sensitivity to cold

itchiness, 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. 

Warnings

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 direted 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?

1-800-328-5890

Package Labeling:

Bottle3 (Bottle3)

Bottle3 (Bottle3)

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