DRY EYE RELIEF TRIAL SIZE 15X- belladonna, euphrasia officinalis, mercurius sublimatus, solution/ drops

Dry Eye Relief Trial Size 15x by

Drug Labeling and Warnings

Dry Eye Relief Trial Size 15x by is a Homeopathic medication manufactured, distributed, or labeled by Similasan AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dry Eye Relief Trial Size

Active Ingredient

Belladonna* 6X

*containing 0.000002% alkaloids calculated as hyoscyamine.

Purpose

dryness, redness

Active Ingredient

Euphrasia officinalis (Eyebright) 6X

Purpose

redness

Active Ingredient

Mercurius sublimatus 15X

Purpose

dryness, watering

Uses*

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

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

Warnings

• For external use only.
  
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
  
• Use only if single-use dropper is intact.
  
• To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.
  
• Contact wearers: consult a 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 solution changes color or becomes cloudy

Stop use and ask a doctor if:

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

Directions

For adults and children age 2 and over:

• twist flat end with ball to open
  
• squeeze plastic dropper to release 2-3 drops into eye and discard applicator
  
• apply as needed

Inactive Ingredients

Phosphate buffer, Purified water

Principal Display Panel

Similasan
Dry Eye
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz (one vial)

INGREDIENTS AND APPEARANCE

DRY EYE RELIEF TRIAL SIZE 15X 
belladonna, euphrasia officinalis, mercurius sublimatus, solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53799-376
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 CATION	15 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM NITRATE (UNII: 8M4L3H2ZVZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53799-376-13	.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product	07/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/08/2021

Labeler - Similasan AG (481545754)