SWIMMERS EAR RELIEF- anemone pulsatilla, graphite and sulfur liquid

Swimmers Ear Relief by

Drug Labeling and Warnings

Swimmers Ear Relief by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

NDC: 59262-278-11
Similasan
Swimmer’s Ear Relief
Ear Drops
10 ml/ 0.33 fl oz

INGREDIENTS AND APPEARANCE

SWIMMERS EAR RELIEF 
anemone pulsatilla, graphite and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-278
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-278-11	1 in 1 CARTON	12/15/2020
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/15/2020

Labeler - Similasan Corporation (111566530)