FDA Label for Irritated Eye Relief
View Indications, Usage & Precautions
Irritated Eye Relief Product Label
The following document was submitted to the FDA by the labeler of this product Similasan Corporation. 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*
*containing 0.000002% alkaloids calculated as hyoscyamine
Euphrasia 6X
Hepar sulphuris 12X
Purpose
dryness, redness, burning, sensation of grittiness
watery discharge
redness, stinging
Uses:
According to homeopathic principles, the active ingredients in this medication help to temporarily relieve symptoms of:
- redness of the eyes
- excessive watery (clear) discharge
- sensation of grittiness
- irritation, dryness, and burning
Warnings:
- For external use only.
- Children under 2 years of age should be seen by a physician.
- Initial exacerbation of symptoms may occur.
- 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.
- Replace cap tightly after every use.
- 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
- if you experience eye pain or changes in vision
Stop Use And Ask A Doctor If:
- symptoms worsen or persist for more than 72 hours
- changes in vision occur
- you might have a serious underlying medical cause for the infection
Directions:
For adults and children ages 2 and over:
- remove tamper-evident seal from neck of bottle
- twist cap off 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 sulphate (as preservative), Sodium nitrate
Questions?
Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com
Prinicipal Display Panel
NDC 59262-348-11
Similasan
Irritated Eye Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz
* Please review the disclaimer below.
