EARACHE DROPS- chamomilla, mercurius solubilis and sulphur solution/ drops

Earache Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients -

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

sensitivity to drafts, soothing

fullness, sensitivity to cold

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. 1-800-222-1222

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 you have:

ear drainage or discharge

pain, irritation, or rash in the ear

had ear surgery

dizziness

Directions

FOR USE IN THE EAR ONLY.

Remove tamper-evident seal from neck of bottle.

Twist cap off bottle.

Tilt head sideways.

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

Keep drops in ear for 3 to 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.

Children under 12 years of age consult a doctor.

Other information

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient

Purified water, Vegetable glycerin

Questions?

1-800-250-9780

PRINCIPAL DISPLAY PANEL

Earache
Drops

0.33 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

EARACHE DROPS 
chamomilla, mercurius solubilis and sulphur solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-405
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
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-405-11	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/16/2021

Labeler - Similasan AG (481545754)

Registrant - Walgreen Company (008965063)