FDA Label for Dry Eye Nighttime
View Indications, Usage & Precautions
Dry Eye Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Similasan Ag. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Belladonna* 6X
Euphrasia officinalis (Eyebright) 6X
Mercurius sublimatus 15X
Purpose
dryness, redness
redness
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 [email protected].
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
* Please review the disclaimer below.