FDA Label for Pink Eye Nighttime
View Indications, Usage & Precautions
Pink Eye Nighttime 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 Ingredients
Belladonna 6X†
†containing 0.000002% alkaloids calculated as hyoscyamine
Euphrasia officinalis (Eyebright) 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 product temporarily relieve minor eye symptoms:
• excessive watery (clear) discharge
• sensation of grittiness
• redness and burning
Warnings
• For external use only.
• 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 bottle 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 wearers: consult physician prior to using.
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:
• you experience eye pain or changes in vision
• symptoms worsen or persist for more than 72 hours
• you might have a serious underlying medical cause for an infection
Directions
For adults and children ages 2 and over:
• remove tamper-evident seal from neck of bottle
• twist cap off bottle
• DON’T squeeze bottle, squeeze plastic tip to release 1-2 drops into eye
• apply as needed
• replace cap after use
Other Information
• Active ingredients are manufactured according to homeopathic principles.
• Store below 86°F
Inactive Ingredients
Borate buffer, Purified water, Silver sulfate (as preservative), Sodium hyaluronate, Sodium nitrate
Questions?
Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com
For your protection do not use if tamper evident seal around neck of bottle is missing or broken.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Principal Display Panel
NDC 59262-377-11
Similasan
Pink eye
Nighttime
Gel™
10 mL/ 0.33 fl oz
* Please review the disclaimer below.