KIDS EAR RELIEF- chamomile, mercurius solubilis, pulsatilla patens 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

Pulsatilla 12X

Purpose

night time calmative

Active Ingredient

Sulphur 12X

Purpose

itchiness, sensitivity to water

Uses:

Helps 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 may occur.

Ask a doctor before use if the child has:

  • 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

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
For children ages 2 and over:

  • Remove tamper-evident seal from neck of bottle.
  • Twist cap off bottle.
  • Tilt child's 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.

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.SimilasanUSA.com

Principle Display Panel

HOMEOPATHIC
NDC 59262-274-11
Similasan
Kids 
Ear
Relief
ear drops
10 ml
0.33 fl oz

HOMEOPATHIC NDC 59262-274-11 Similasan Kids Ear Relief ear drops 10 ml 0.33 fl oz

KIDS EAR RELIEF 
chamomile and mercurius solubilis and pulsatilla patens and sulphur solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-274
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
PULSATILLA PATENS (PULSATILLA PATENS) PULSATILLA PATENS12 [hp_X]  in 10 mL
SULFUR (SULFUR) SULFUR12 [hp_X]  in 10 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:53799-274-1110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC01/01/2007
Labeler - Similasan AG (481545754)

Revised: 05/2012
 
Similasan AG