KIDS EARACHE RELIEF- matricaria recutita, mercurius solubilis, anemone patens and sulphur solution

Kids Earache Relief by

Drug Labeling and Warnings

Kids 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 – Kids 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.

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 4-5 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

Vegetable glycerin

Questions?

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

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

Similasan
Kids 
Earache
Relief
EAR DROPS
10 ml / 0.33 fl oz

INGREDIENTS AND APPEARANCE

KIDS EARACHE RELIEF 
matricaria recutita, mercurius solubilis, anemone patens and sulphur solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-279
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	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: 53799-279-11	1 in 1 BOX	07/20/2018
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/20/2018

Labeler - Similasan AG (481545754)