EAR RELIEF- chamomilla and mercurius solubilis and sulphur solution

Earache Relief by

Drug Labeling and Warnings

Earache Relief by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation, Similasan AG. 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:

Helps temporarily 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 of symptoms 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.
• Squeeze plastic applicator and 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.

Inactive ingredient:

Vegetable glycerin

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com
www.SimilisanUSA.com

PRINCIPAL DISPLAY PANEL

NDC: 59262-271-11
Similasan
Ear Relief
EAR DROPS
10 ml / 0.33 fl oz

INGREDIENTS AND APPEARANCE

EAR RELIEF 
chamomilla and mercurius solubilis and sulphur solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-271
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: 59262-271-11	10 mL in 1 BOTTLE, GLASS; 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		07/02/2013

Labeler - Similasan Corporation (111566530)