Active Ingredients
Belladonna 6X†
†containing 0.000002% alkaloids calculated as hyoscyamine
Euphrasia officinalis (Eyebright) 6X
Hepar sulphuris 12X
Pink Eye Relief
FDA Label NDC 53799-365
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Ag for the product Pink Eye Relief (NDC 53799-365). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses*, warnings, keep out of reach of children., do not use:, stop use and ask a doctor if:, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 lens 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 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 sulfate (as preservative), 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.
*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Principal Display Panel
NDC 53799-365-11
Similasan
Pink Eye Relief
10 mL/ 0.33 fl oz
Principal Display Panelndc 53799-365-11similasanpink Eye Relief10 mL/ 0.33 Fl Oz (Pink Eye Relief 01)
* Please review the disclaimer below.
