CHILDRENS EARACHE RELIEF- chamomilla 10x, mercurius solubilis 15x, pulsatilla 12x, sulphur 12x 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.

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Childrens Earache Relief

Drug Facts – Children’s Earache Relief

Active ingredients

Chamomilla 10X

Mercurius solubilis 15X

Pulsatilla 12X

Sulphur 12X

Purpose

sensitivity to drafts, soothing

fullness, sensitivity to cold

night time calmative

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.

Children under 2 years of age should be seen by a physician.

• 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 the child has:

• ear drainage or discharge

• pain, irritation, or rash in the ear

• had ear surgery

• dizziness

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.

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

• Keep drops in ear for 3-5 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.

Other information

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient

Purified water, Vegetable glycerin

Questions?

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

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-274-11
Similasan
Children’s
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz

PRINCIPAL DISPLAY PANEL
NDC 59262-274-11
Similasan
Children’s 
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz

PRINCIPAL DISPLAY PANEL
NDC 59262-274-11
Similasan
Children’s 
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz

CHILDRENS EARACHE RELIEF 
chamomilla 10x, mercurius solubilis 15x, pulsatilla 12x, sulphur 12x solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-274
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
PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE12 [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:59262-274-1110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2007
Labeler - Similasan Corporation (111566530)

Revised: 4/2021
Document Id: 7b31b0e7-ff51-4b0f-8ee0-aa78e6d676d0
Set id: 47258c11-ddd8-4ce1-83a4-6fb5295c73aa
Version: 3
Effective Time: 20210422
 
Similasan Corporation