Active Ingredients
Belladonna† 6X
Euphrasia officinalis (Eyebright) 6X
Mercurius sublimatus 15X
Complete Eye Relief
FDA Label NDC 53799-373
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 Complete Eye Relief (NDC 53799-373). 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, if pregnant, trying to get pregnant or breast feeding,, keep out of reach of children., do not use:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
dryness, redness, burning
irritation, grittiness, watering
burning, redness
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• redness of eyes and eye lids
• dry eye
• reflex watering secondary to dry eye
• sensation of grittiness
• sensation of burning
Warnings
• For external use only.
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• Replace cap tightly after every use.
• 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.
• Contact wearers: consult a physician prior to using.
If Pregnant, Trying To Get 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.
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 tamper-evident seal from neck of bottle
• twist cap off bottle
• DON'T squeeze bottle, squeeze plastic tip to release 2 to 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
†containing 0.000002% alkaloids calculated as hyoscyamine
Principal Display Panel
Complete
Eye Relief
STERILE
EYE DROPS
10 ml/ 0.33 fl oz
Principal Display Panelcompleteeye Reliefsterileeye Drops10 mL/ 0.33 Fl Oz (Complete Eye Relief 01)
* Please review the disclaimer below.
