EAR RELIEF EAR DROPS- chamomilla, mercurius solubilis, and sulphur solution

Ear Relief Ear Drops by

Drug Labeling and Warnings

Ear Relief Ear Drops by is a Homeopathic medication manufactured, distributed, or labeled by We Care Distributor Inc., PURINE PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	10 [hp_X]  in 10 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	15 [hp_X]  in 10 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-034-01	1 in 1 BOX	09/23/2016
1		10 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

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	Business Operations
PURINE PHARMA LLC		019950491	manufacture(70005-034)