Earache Drops: Homeopathic Product Information

EARACHE DROPS- chamomile, mercurius solubilis and sulfur solution/ drops
Similasan AG

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.

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 c hildren.

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)

Earache
Drops

0.33 FL OZ (10 mL)
(click image for full-size original)
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) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAMOMILE (CHAMOMILE) CHAMOMILE 10 [hp_X] in 10 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 15 [hp_X] in 10 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53799-405-11 10 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 09/08/2021
Labeler — Similasan AG (481545754)
Registrant — Walgreen Company (008965063)

Revised: 09/2021 Similasan AG

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