ear wax relief

SPL v12

SPL

SPL Set ID 1b548338-f9f0-4a63-b553-df4fcd18d594

Route

auricular (otic)

Published

Effective Date 2025-04-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

causticum (12 [hp_X]) graphite (15 [hp_X]) lachesis muta venom lycopodium clavatum spore

Inactive Ingredients

glycerin

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2003-06-01

Purpose

itching, wax build-up

Description

Causticum 12X

Medication Information

Purpose

itching, wax build-up

Description

Causticum 12X

Questions?

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

www.SimilasanUSA.com

Uses:

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

clogged sensation when caused by ear wax
ringing in the ear when caused by ear wax
dry skin and itching of the ear canal

Warnings:

According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
Avoid contact with eyes.

Directions:

FOR USE IN THE EAR ONLY.

For adults and children, over 12 years of age:

Remove tamper evident seal from neck of bottle.
Twist cap off bottle.
Tilt head sideways, squeeze plastic applicator to release 2-3 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 twice daily for up to 2 days if needed, or as directed by a doctor.
Any wax remaining after treatment may be removed by with warm water, using a soft, rubber bulb ear syringe.
Children under 12 years of age: consult a doctor.

Do Not Use:

if you have ear drainage, discharge, ear pain, irritation, a rash in the ear, or are dizzy; consult a doctor
if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
for more than 48 hours; if excessive ear wax remains after the use of this product, consult a doctor
with ear tubes

Active Ingredient

Causticum 12X

Active Ingredients

Graphites 15X

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredient:

Vegetable glycerin

Principle Display Panel

NDC 59262-272-11

Similasan

Ear Wax Relief

EAR DROPS

10 ml / 0.33 fl oz

Keep Out of Reach of Children.

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

If Pregnant, Trying to Get Pregnant Or Breast Feeding,

ask a health professional before use.

Structured Label Content

Purpose

itching, wax build-up

Questions?

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

www.SimilasanUSA.com

Uses:

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

clogged sensation when caused by ear wax
ringing in the ear when caused by ear wax
dry skin and itching of the ear canal

Warnings:

According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
Avoid contact with eyes.

Directions:

FOR USE IN THE EAR ONLY.

For adults and children, over 12 years of age:

Remove tamper evident seal from neck of bottle.
Twist cap off bottle.
Tilt head sideways, squeeze plastic applicator to release 2-3 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 twice daily for up to 2 days if needed, or as directed by a doctor.
Any wax remaining after treatment may be removed by with warm water, using a soft, rubber bulb ear syringe.
Children under 12 years of age: consult a doctor.

Do Not Use: (Do not use:)

if you have ear drainage, discharge, ear pain, irritation, a rash in the ear, or are dizzy; consult a doctor
if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor
for more than 48 hours; if excessive ear wax remains after the use of this product, consult a doctor
with ear tubes

Active Ingredient

Causticum 12X

Active Ingredients

Graphites 15X

Other Information: (Other information:)

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredient: (Inactive ingredient:)

Vegetable glycerin

Principle Display Panel

NDC 59262-272-11

Similasan

Ear Wax Relief

EAR DROPS

10 ml / 0.33 fl oz

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.

If Pregnant, Trying to Get Pregnant Or Breast Feeding, (If pregnant, trying to get pregnant or breast feeding,)

ask a health professional before use.

Advanced Ingredient Data

[{"name": "CAUSTICUM", "unii": "DD5FO1WKFU", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "10", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "GRAPHITE", "unii": "4QQN74LH4O", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "10", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "LACHESIS MUTA VENOM", "unii": "VSW71SS07I", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "10", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "LYCOPODIUM CLAVATUM SPORE", "unii": "C88X29Y479", "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 minor symptoms such as: clogged sensation when caused by ear wax ringing in the ear when caused by ear wax dry skin and itching of the ear canal", "Purpose": "itching, wax build-up", "Warnings:": "According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms). Avoid contact with eyes.", "Questions?": "Reach our representatives at: 1-800-240-9780 or getinfo@similasanusa.com www.SimilasanUSA.com", "Directions:": "FOR USE IN THE EAR ONLY. For adults and children, over 12 years of age: Remove tamper evident seal from neck of bottle. Twist cap off bottle. Tilt head sideways, squeeze plastic applicator to release 2-3 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 twice daily for up to 2 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by with warm water, using a soft, rubber bulb ear syringe. Children under 12 years of age: consult a doctor.", "Do not use:": "if you have ear drainage, discharge, ear pain, irritation, a rash in the ear, or are dizzy; consult a doctor if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor for more than 48 hours; if excessive ear wax remains after the use of this product, consult a doctor with ear tubes", "Active Ingredient": "Causticum 12X", "Active Ingredients": "Graphites 15X", "Other information:": "Active ingredients are manufactured according to homeopathic principles.", "Inactive ingredient:": "Vegetable glycerin", "Principle Display Panel": "NDC 59262-272-11 Similasan Ear Wax Relief EAR DROPS 10 ml / 0.33 fl oz", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "If pregnant, trying to get pregnant or breast feeding,": "ask a health professional before use."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:01.789898 · Updated: 2026-03-14T23:17:20.751290