FDA.reportPublic FDA data

Swimmers Ear Relief Ear Drops

Manufacturer
Similasan AG
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:12

Label at a glance#

ProductSwimmers Ear Relief Ear Drops
Active ingredientANEMONE PULSATILLA, GRAPHITE, SULFUR
Label structure14 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve swimmer’s ear symptoms such as: • pain in ears, humming • blocked sensation in ears • itchiness, sensitivity to water

Dosage and administration

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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Pulsatilla 12X

Purpose

OTC - PURPOSE SECTION

pain in ears, humming

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Graphites 12X

Purpose

OTC - PURPOSE SECTION

blocked sensation in ears

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sulphur 12X

Purpose

OTC - PURPOSE SECTION

itchiness, sensitivity to water

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve swimmer’s ear symptoms such as:

• pain in ears, humming

• blocked sensation in ears

• itchiness, sensitivity to water

Warnings

WARNINGS SECTION

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Stop use and ask a doctor if:

OTC - STOP USE SECTION

• 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:

OTC - ASK DOCTOR SECTION

• ear drainage or discharge

• pain, irritation, or rash in the ear

• had ear surgery

• dizziness

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Purified water, Vegetable glycerin

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Similasan
Swimmer’s Ear Relief
Ear Drops
10 ml/ 0.33 fl oz

Similasan Swimmer’s Ear Relief Ear Drops 10 ml/ 0.33 fl ozSimilasan Swimmer’s Ear Relief Ear Drops 10 ml/ 0.33 fl oz

Similasan Swimmer’s Ear Relief Ear Drops 10 ml/ 0.33 fl ozSimilasan Swimmer’s Ear Relief Ear Drops 10 ml/ 0.33 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-278-112025-01-30C16284748780-12cef2736-9a41-d83d-e063-dadaa90ab31fSwimmers Ear Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-278-11Swimmers Ear Relief Ear Drops10 mL in 1 BOTTLE, DROPPERLIQUID102
53799-278-11Swimmers Ear Relief Ear Drops1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-278SWIMMERS EAR RELIEF EAR DROPS (ANEMONE PULSATILLA, GRAPHITE AND SULFUR) LIQUID [SIMILASAN AG]2Legacy NDC, 2 package rows20230106_29ecb3ae-0e89-4b4e-b0f0-3b6fbb6ffe40.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-27853799-278-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANEMONE PULSATILLAI76KB35JEVACTIB
GRAPHITE4QQN74LH4OACTIB
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
340c26fe-613c-435b-89e7-d3a3d09c7e9e29ecb3ae-0e89-4b4e-b0f0-3b6fbb6ffe402020-12-02WarningsExact identifier
spl id: 340c26fe-613c-435b-89e7-d3a3d09c7e9e
spl set id: 29ecb3ae-0e89-4b4e-b0f0-3b6fbb6ffe40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.