SWIMMERS EAR RELIEF EAR DROPS- anemone pulsatilla, graphite and sulfur liquid 
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.

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Swimmers Ear Relief

Drug Facts

Active ingredients

Pulsatilla 12X

Purpose

pain in ears, humming

Active ingredients

Graphites 12X

Purpose

blocked sensation in ears

Active ingredients

Sulphur 12X

Purpose

itchiness, sensitivity to water

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

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.

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?

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

www.SimilasanUSA.com

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 oz

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

SWIMMERS EAR RELIEF EAR DROPS 
anemone pulsatilla, graphite and sulfur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-278
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA12 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53799-278-111 in 1 CARTON12/15/2020
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/15/2020
Labeler - Similasan AG (481545754)

Revised: 12/2020
Document Id: 340c26fe-613c-435b-89e7-d3a3d09c7e9e
Set id: 29ecb3ae-0e89-4b4e-b0f0-3b6fbb6ffe40
Version: 2
Effective Time: 20201202
 
Similasan AG