CHILDRENS EARACHE RELIEF- chamomile, mercurius solubilis, pulsatilla patens whole and sulfur solution

Childrens Earache Relief by

Drug Labeling and Warnings

Childrens Earache Relief by is a Homeopathic medication manufactured, distributed, or labeled by Similasan AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Similasan
Children’s
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz

INGREDIENTS AND APPEARANCE

CHILDRENS EARACHE RELIEF 
chamomile, mercurius solubilis, pulsatilla patens whole and sulfur solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-276
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	10 [hp_X]  in 10 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	15 [hp_X]  in 10 mL
PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD)	PULSATILLA PATENS WHOLE	12 [hp_X]  in 10 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-276-11	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/22/2021

Labeler - Similasan AG (481545754)