EAR RELIEF- chamomile, mercurius solubilis and sulfur solution 
Similasan AG

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 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 relief 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 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 email us at getinfo@similasanusa.com
www.SimilisanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-271-11
Similasan® Ear Relief
100% Natural Active Ingredients
Ear Drying Aid, Relieves the Symptoms of Clogged Ears
10 ml/ 0.33 fl oz
NDC 59262-271-11 Similasan® Ear Relief 100% Natural Active Ingredients Ear Drying Aid, Relieves the Symptoms of Clogged Ears 10 ml/ 0.33 fl oz

EAR RELIEF 
chamomilla and mercurius solubilis and sulphur solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-271
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHAMOMILE (CHAMOMILE) CHAMOMILE10 [hp_X]  in 10 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS15 [hp_X]  in 10 mL
SULFUR (SULFUR) SULFUR12 [hp_X]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:53799-271-1110 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC01/01/199807/02/2013
Labeler - Similasan AG (481545754)

Revised: 08/2013
Document Id: 08a5cae0-dd50-45b1-b8a7-0e92021986e6
Set id: 2d07e35a-a835-435f-a92f-723666171755
Version: 5
Effective Time: 20130815
 
Similasan AG