Active Ingredients
Belladonna† 6X
Euphrasia officinalis (Eyebright) 6X
Mercurius sublimatus 15X
Dry Eye Relief
FDA Label NDC 53799-300
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 Dry Eye Relief (NDC 53799-300). 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
redness
dryness, watering
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• dry eye
• redness of eyes and lids
• reflex watering secondary to dry eye
Warnings
• For external use only.
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• 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 lens wearers: consult a 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 solution changes color or becomes cloudy
Stop Use And Ask A Doctor If:
• symptoms worsen or persist for more than 72 hours
• you experience eye pain or changes in vision
Directions
For adults and children age 2 and over:
• 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
• apply as needed
• use a new dropper for every application
Other Information
Active ingredients are manufactured according to homeopathic principles.
Inactive Ingredients
Phosphate buffer, Purified water
Questions?
Reach our representatives at 1-800-240-9780 or [email protected]
www.SimilasanUSA.com
Principal Display Panel
Dry Eye
Relief
0.4 ml/0.014 fl oz each
Dry Eyerelief0.4 mL/0.014 Fl Oz Each (Dry Eye Relief Monodose 15x 01)
* Please review the disclaimer below.
