Quality Choice Ear Relief Drops: Homeopathic Product Information

QUALITY CHOICE EAR RELIEF DROPS- matricaria chamomilla whole, mercurius solubilis and sulfur solution/ drops
Chain Drug Marketing Association

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Facts

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.

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 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:

Label3
(click image for full-size original)

QUALITY CHOICE EAR RELIEF DROPS
matricaria chamomilla whole, mercurius solubilis, sulfur solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-604
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MATRICARIA CHAMOMILLA WHOLE (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA WHOLE 10 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 15 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63868-604-01 1 BOTTLE in 1 BOX contains a BOTTLE
1 12 mL in 1 BOTTLE This package is contained within the BOX (63868-604-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/01/2013
Labeler — Chain Drug Marketing Association (011920774)
Establishment
Name Address ID/FEI Operations
Bell Pharmaceuticals, Inc. 140653770 manufacture (63868-604)

Revised: 03/2020 Chain Drug Marketing Association

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