DRY EYE NIGHTTIME- atropa belladonna, euphrasia stricta and mercuric chloride gel

Dry Eye Nighttime by

Drug Labeling and Warnings

Dry Eye Nighttime by is a Homeopathic medication manufactured, distributed, or labeled by Similasan AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient

Belladonna* 6X

Purpose

dryness, redness

Active Ingredient

Euphrasia officinalis (Eyebright) 6X

Purpose

redness

Active Ingredient

Mercurius sublimatus 15X

Purpose

dryness

Uses:

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

• dry eye
  
• redness of eyes and lids
  
• reflex watering secondary to dry eye

Warnings:

• For external use only (in the eye).
  
• Children under 2 years of age should be seen by a physician.
  
• According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
  
• To avoid contamination, do not touch the tip of the container to any surface.
  
• To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.
  
• Replace cap tightly after every use.
  
• Contact lens wearers: consult physician prior to using.

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 the gel changes color or becomes cloudy

Stop use and ask a doctor if:

• you experience eye pain or changes in vision
  
• 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 1 to 2 drops into eye
  
• apply as needed
  
• replace cap after use

Other Information:

• Active ingredients are manufactured according to homeopathic principles.
  
• Store below 86° F / 30° C

Inactive Ingredients

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

Questions?

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

*containing ≤0.000002% alkaloids calculated as hyoscyamine

Principle Display Panel

Similasan
Dry Eye Nighttime Gel
Sterile Gel Eye Drops
10 ml / 0.33 fl oz

INGREDIENTS AND APPEARANCE

DRY EYE NIGHTTIME 
atropa belladonna, euphrasia stricta and mercuric chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-378
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]  in 10 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 10 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	15 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILVER SULFATE (UNII: 8QG6HV4ZPO)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-378-11	1 in 1 CARTON	01/25/2022
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		01/25/2022

Labeler - Similasan AG (481545754)