Ear Relief Ear Drops: Homeopathic Product Information

EAR RELIEF EAR DROPS- chamomile, mercurius solubilis and sulfur solution
We Care Distributor Inc.

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.

Active ingredient

Chamomilla 10X

Purpose

sensitivity to drafts, soothing

Active ingredient

Mercurius solubilis 15X

Purpose

fullness, sensitivity to cold

Active ingredient

Sulphur 12X

Purpose

itchiness, sensitivity to water

Uses:

According to homeopathic principles the ingredients of this medication give you temporary relief from symptoms due to:

  • drafts and the annoyance of water-clogged ears by helping clear water trapped in the ear.

Warnings:

  • Do not use in the eyes.
  • Do not take internally by mouth
  • Initial exacerbation may occur.
  • The preparation must not be used if there is any damage to the ear drum, do not use with ear tubes.
  • This product does not treat ear aches caused by an ear infection. Ear infections must be treated by a physician and proper medication that must be prescribed by a physician.
  • If ear infections are not treated properly then may cause loss of hearing and deafness.
  • Use only if bottle seal in intact.

Ask a doctor before use if you have:

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

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 consult a Poison Control Center right away.

Directions:

  • Remove tamper proof seal
  • Tilt head sideways
  • Apply 3-4 drops into affected ear from one to several times daily for no more than 48 hours, or as directed by a physician
  • Tip of the bottle should not enter ear canal
  • Keep drops in ear by keeping head tilted or placing cotton in ear.
  • Use before expiration date
  • For ages 2 and over

Other information:

  • Store in a cool and dry place, Protect from sunlight and moisture
  • Keep in a tightly closed container

Inactive ingredient:

Glycerin, USP

Questions?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

Ear Relief Ear Drops
EAR DROPS

10 ml / 0.33 fl oz

Ear Relief EAR DROPS 10 ml / 0.33 fl oz
(click image for full-size original)

EAR RELIEF EAR DROPS
chamomilla, mercurius solubilis, and sulphur solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-034
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAMOMILE (CHAMOMILE) CHAMOMILE 10 [hp_X] in 10 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 15 [hp_X] in 10 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 10 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70005-034-01 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (70005-034-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED HOMEOPATHIC 09/23/2016
Labeler — We Care Distributor Inc. (079832998)
Establishment
Name Address ID/FEI Operations
PURINE PHARMA LLC 019950491 manufacture (70005-034)

Revised: 09/2016 We Care Distributor Inc.

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