Dry Eye Nighttime
FDA Label NDC 53799-378

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 Nighttime (NDC 53799-378). 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

Euphrasia officinalis (Eyebright) 6X

Mercurius sublimatus 15X

Purpose

dryness, redness

redness

dryness

Uses:

According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as:

  • dry eye
  • redness of eyes and lids
  • reflex watering secondary to dry eye

Warnings:

  • For external use only (in the eye).
  • 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 container 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.

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 gel 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

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 1 to 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 / 30° C

Inactive Ingredients

Borate buffer, Purified water, Silver sulphate (as preservative), Sodium hyaluronate, Sodium nitrate

Questions?

Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com

*containing ≤0.000002% alkaloids calculated as hyoscyamine

Principle Display Panel

Similasan
Dry Eye Nighttime Gel
Sterile Gel Eye Drops
10 ml / 0.33 fl oz

Similasandry Eye Nighttime Gelsterile Gel Eye Drops10 mL / 0.33 Fl Oz (Dry Eye Nighttime Gel 01)

Similasandry Eye Nighttime Gelsterile Gel Eye Drops10 mL / 0.33 Fl Oz (Dry Eye Nighttime Gel 01)

Similasandry Eye Nighttime Gelsterile Gel Eye Drops10 mL / 0.33 Fl Oz (Dry Eye Nighttime Gel 02)

Similasandry Eye Nighttime Gelsterile Gel Eye Drops10 mL / 0.33 Fl Oz (Dry Eye Nighttime Gel 02)

* Please review the disclaimer below.