Dry Eye Relief Trial Size 15x
FDA Label NDC 53799-376

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 Trial Size 15x (NDC 53799-376). 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 ingredient, 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

Active Ingredient

Belladonna* 6X

*containing 0.000002% alkaloids calculated as hyoscyamine.

Euphrasia officinalis (Eyebright) 6X

Mercurius sublimatus 15X

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 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:

  • twist flat end with ball to open
  • squeeze plastic dropper to release 2-3 drops into eye and discard applicator
  • apply as needed

Inactive Ingredients

Phosphate buffer, Purified water

Principal Display Panel


Similasan
Dry Eye
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz (one vial)


Principal Display Panelsimilasandry Eye Reliefsingle-use Sterile Eye Dropspreservative Free0.4 mL/ 0.014 Fl Oz (one Vial) (Dry Eye Relief Trial Size 15x 01)

Principal Display Panelsimilasandry Eye Reliefsingle-use Sterile Eye Dropspreservative Free0.4 mL/ 0.014 Fl Oz (one Vial) (Dry Eye Relief Trial Size 15x 01)


Principal Display Panelsimilasandry Eye Reliefsingle-use Sterile Eye Dropspreservative Free0.4 mL/ 0.014 Fl Oz (one Vial) (Dry Eye Relief Trial Size 15x 02)

Principal Display Panelsimilasandry Eye Reliefsingle-use Sterile Eye Dropspreservative Free0.4 mL/ 0.014 Fl Oz (one Vial) (Dry Eye Relief Trial Size 15x 02)


Principal Display Panelsimilasandry Eye Reliefsingle-use Sterile Eye Dropspreservative Free0.4 mL/ 0.014 Fl Oz (one Vial) (Dry Eye Relief Trial Size 15x 03)

Principal Display Panelsimilasandry Eye Reliefsingle-use Sterile Eye Dropspreservative Free0.4 mL/ 0.014 Fl Oz (one Vial) (Dry Eye Relief Trial Size 15x 03)

* Please review the disclaimer below.