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 relieve:
- 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.
- 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 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 you are experiencing a think, white, yellow, or green discharge that forms a crust on the eyelid
- if the solution changes color or becomes cloudy
- if you experience eye pain or changes in vision
- if you frequently contract infections that do not clear up easily
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:
- Remove a single-use dropper
- Twist flat end with ball to remove
- Squeeze plastic dropper to release 2-3 drops into eye and discard applicator
Inactive Ingredients:
Phosphate buffer, Purified water
Prinicipal Display Panel
HOMEOPATHIC
NDC 59262-356-13
Similasan
Irritated
Eye Relief
sterile eye droppers
0.45 ml / 0.015 fl oz each
(0.9 ml / 0.03 fl oz total)
SIMILASAN / USA
30033
Irritated Eye Relief, eye drops,
Single-Use Droppers
2 x 0.45 ml, Trial size buffered
200 pieces (Stk.)
Batch
000000
Exp.
00/0000
* Please review the disclaimer below.