REDNESS AND ITCHY EYE RELIEF- apis mellifera, euphrasia stricta, pulsatilla vulgaris and schoenocaulon officinale seed solution/ drops

Redness and Itchy Eye Relief by

Drug Labeling and Warnings

Redness and Itchy Eye 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

Drug Facts

Active Ingredient

Apis mellifica 6X 

Purpose

stinging, burning, itching

Active Ingredient

Euphrasia officinalis (Eyebright) 6X

Purpose

redness, irritation

Active Ingredient

Pulsatilla 6X

Purpose

itching, burning, redness, watering

Active Ingredient

Sabadilla 6X

Purpose

watering, redness of lids

Uses:

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

• itching            
  
• burning
  
• redness of eyes and lids      
  
• stinging
  
• excessive watering      
  
• irritation

Warnings:

• For external use only.
  
• Initial exacerbation of symptoms may occur.
  
• Replace cap tightly after every use.
  
• To avoid contamination, do not touch the tip of the container to any surface.
  
• Use within 30 days of opening. Expiration date only refers to unopened bottle.
  
• Contact wearers: consult a physician prior to using.

If 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 the solution changes color or becomes cloudy

Stop use and ask a doctor if:

• changes in vision occur
  
• you experience eye pain
  
• symptoms worsen or persist for more than 72 hours

Directions:

For adults and children age 2 and over:

• remove tamper-evident seal from neck of bottle
  
• twist cap off bottle
  
• DON’T squeeze bottle, squeeze plastic tip to release 2-3 drops into eye
  
• apply as needed
  
• replace cap after use

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

Borate buffer, Purified water, Silver sulfate (as preservative), Sodium nitrate

Questions?

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

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

NDC 59262-363-11
Similasan®
Redness &
Itchy Eye
Relief
STERILE
EYE DROPS
10 mL/0.33 fl oz

INGREDIENTS AND APPEARANCE

REDNESS AND ITCHY EYE RELIEF 
apis mellifera, euphrasia stricta, pulsatilla vulgaris and schoenocaulon officinale seed solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-363
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X]  in 10 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 10 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]  in 10 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
SILVER SULFATE (UNII: 8QG6HV4ZPO)
SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-363-11	1 in 1 BOX
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		01/01/2015

Labeler - Similasan Corporation (111566530)

Establishment
Name	Address	ID/FEI	Business Operations
Similasan AG		481545754	LABEL(59262-363) , MANUFACTURE(59262-363) , PACK(59262-363)