EARACHE RELIEF - chamomile, mercurius solubilis and sulfur solution
Similasan Corporation

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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredients               Purpose
Chamomilla 10X               calmative, pain reliever
Mercurius solubilis 15X       anti-inflammatory, pain reliever
Sulphur 12X                        pain reliver, anti-itch

Uses:

Uses:
According to homeopathic principles, the active ingredinets in this medication provide temporary relief from earache (ear pain) in children and adults due to:
drafts
colds
flu
swimmer's ear

Warnings:

Warnings:
For external use only
A physician should be consulted about earache in children as a matter of principle.
Initial exacerbation of symptoms may occur.
Keep this and all medicines out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Do not use:

Do Not Use:
if you have ear drainage, discharge, irritation, a rash in the ear, or are dizzy; consult a doctor.
with ear tubes, after ear surgery or with damaged ear drums.

Stop use and ask a doctor if:

Stop use and ask a doctor if:
symptoms persist for more than 48 hours
these is discharge from the ear
there is a fever of 102F or greater

Directions:

Directions:
FOR USE IN THE EAR ONLY
For adults and children, including toddlers and infants:
remove tamper-evident seal from neck of bottle
twist cap off bottle
tilt head sideways
squeeze plastic applicator to release 2-3 drops into ear (applicator should not enter ear canal)
keep drops in ear by keeping head tilted or placing cotton in ear
repeat as needed, use when pain reoccurs

Other information:

Other information
Active ingredients are micro diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects

Inactive ingredient:

Inactive Ingredient:
Vegetable glycerin

Questions?

Questions?
Reach our representatives, M-F, 8am-5pm (MT), or our 24 hour recorded product information at 1-800-240-9780. Visit us: www.SimilasanUSA.com

Homeopathic
NDC 59262-271-11
Similasan
Earache Relief
10 ml/ 0.33 fl oz

EARACHE RELIEF
chamomilla 10x, mercurius solubilis 15x, sulphur 12x solution

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/1998

Labeler - Similasan Corporation (111566530)

Establishment
Name	Address	ID/FEI	Business Operations
Similasan AG		481545754	manufacture

Revised: 02/2010

Document Id: f1aa4574-07d2-4b83-a2a7-d612adbb3bc3

Set id: eb553b17-08b1-4718-a612-16207e8b7bdf

Version: 1

Effective Time: 20100223

Similasan Corporation