earache relief

SPL v6

SPL

SPL Set ID b9749db9-a2e4-4460-8769-6150285a7413

Route

auricular (otic)

Published

Effective Date 2025-02-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

chamomile (10 [hp_X]) mercurius solubilis (15 [hp_X]) sulfur (12 [hp_X])

Inactive Ingredients

glycerin

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2013-07-02

Purpose

sensitivity to drafts, soothing

Description

Drug Facts

Medication Information

Warnings

• Do not use in the eyes.

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)

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

Purpose

sensitivity to drafts, soothing

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.

Description

Drug Facts

Principal Display Panel

Similasan

Earache Relief

Ear Drops

10 ml/ 0.33 fl oz

Questions?

Reach our representatives at 1-800-240-9780 or [email protected]

www.SimilasanUSA.com

Section 42229-5

Drug Facts

Active Ingredients

Chamomilla 10X

Inactive Ingredient

Purified water, Vegetable glycerin

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Ha

• ear drainage or discharge

• pain, irritation, or rash in the ear

• had ear surgery

• dizziness

Structured Label Content

Warnings

• Do not use in the eyes.

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)

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

Purpose

sensitivity to drafts, soothing

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 (Other information)

Active ingredients are manufactured according to homeopathic principles.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Similasan

Earache Relief

Ear Drops

10 ml/ 0.33 fl oz

Questions?

Reach our representatives at 1-800-240-9780 or [email protected]

www.SimilasanUSA.com

Section 42229-5 (42229-5)

Drug Facts

Active Ingredients (Active ingredients)

Chamomilla 10X

Inactive Ingredient (Inactive ingredient)

Purified water, Vegetable glycerin

Stop Use and Ask A Doctor If: (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

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Ha (Ask a doctor before use if you ha)

• ear drainage or discharge

• pain, irritation, or rash in the ear

• had ear surgery

• dizziness

Advanced Ingredient Data

[{"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "10", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "MERCURIUS SOLUBILIS", "unii": "324Y4038G2", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "10", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "10", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "Purpose": "sensitivity to drafts, soothing", "Warnings": "• Do not use in the eyes. • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms)", "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.", "Questions?": "Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com www.SimilasanUSA.com", "Other information": "Active ingredients are manufactured according to homeopathic principles.", "Active ingredients": "Chamomilla 10X", "Inactive ingredient": "Purified water, Vegetable glycerin", "PRINCIPAL DISPLAY PANEL": "Similasan Earache Relief Ear Drops 10 ml/ 0.33 fl oz", "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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you ha": "• ear drainage or discharge • pain, irritation, or rash in the ear • had ear surgery • dizziness"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:58.540964 · Updated: 2026-03-14T23:17:17.103292