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

Kids Ear Relief by

Drug Labeling and Warnings

Kids Ear Relief by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 of symptoms 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

PRINCIPAL DISPLAY PANEL

NDC 59262-273-11
Similasan
Kids Ear Relief
EAR DROPS
10 ml / 0.33 fl oz

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-273
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X]  in 10 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	15 [hp_X]  in 10 mL
ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD)	ANEMONE PATENS	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: 59262-273-11	1 in 1 BOX
1		10 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/15/2014

Labeler - Similasan Corporation (111566530)