EARACHE RELIEF- chamomilla and mercurius solubilis and sulphur 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.

----------

Earache Relief

Drug Facts

Active ingredients

Chamomilla 10X

Purpose

sensitivity to drafts, soothing

Active ingredients

Mercurius solubilis 15X

Purpose

fullness, sensitivity to cold

Active ingredients

Sulphur 12X

Purpose

itchiness, sensitivity to water

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve earache symptoms such as:

• sensation of fullness of the ear

• sensitivity to cold, drafts, and water

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

Warnings

Do not use in the eyes.

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)

If pregnant, trying to get 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.

Stop use and ask a doctor if:

• symptoms persist for more than 48 hours

• there is discharge from the ear

• there is a fever of 102°F or greater

Ask a doctor before use if you have:

• ear drainage or discharge

• pain, irritation, or rash in the ear

• had ear surgery

• dizziness

Directions

FOR USE IN THE EAR ONLY.

• Remove tamper-evident seal from neck of bottle.

• Twist cap off bottle.

• Tilt head sideways.

DON'T squeeze bottle, squeeze plastic tip to release 3 to 5 drops into ear (Tip of applicator should not enter ear canal).

• Keep drops in ear for 3 to 5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer 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.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-277-11
Similasan
Earache Relief
Ear Drops
10 ml/ 0.33 fl oz

NDC 59262-277-11
Similasan
Earache Relief
Ear Drops
10 ml/ 0.33 fl oz

EARACHE RELIEF 
chamomilla and mercurius solubilis and sulphur solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-277
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE10 [hp_X]  in 10 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS15 [hp_X]  in 10 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59262-277-1110 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product07/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC07/02/2013
Labeler - Similasan Corporation (111566530)
Registrant - Similasan AG (481545754)

Revised: 10/2020
Document Id: 4775cc6a-3117-44eb-baef-08ffd1eeaeb5
Set id: eb553b17-08b1-4718-a612-16207e8b7bdf
Version: 10
Effective Time: 20201008
 
Similasan Corporation