EAR WAX RELIEF- causticum, graphite, lachesis muta venom and lycopodium clavatum spore solution

Ear Wax Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient

Causticum 12X

Purpose

itching, wax build-up

Active Ingredients

Graphites 15X

Purpose

dryness, wax build-up

Active Ingredient

Lachesis 12X

Purpose

dryness, wax build-up

Active Ingredient

Lycopodium 12X

Purpose

wax build-up

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.

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.

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

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.

Other information:

Active ingredients are manufactured according to homeopathic principles.

Inactive ingredient:

Vegetable glycerin

Questions?

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

Principle Display Panel

NDC: 59262-272-11
Similasan
Ear Wax Relief
EAR DROPS
10 ml / 0.33 fl oz

INGREDIENTS AND APPEARANCE

EAR WAX RELIEF 
causticum, graphite, lachesis muta venom and lycopodium clavatum spore solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-272
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X]  in 10 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	15 [hp_X]  in 10 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]  in 10 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-272-11	10 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	06/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		06/01/2003

Labeler - Similasan Corporation (111566530)

Registrant - Similasan AG (481545754)