Stye Eye Relief
FDA Label NDC 53799-305

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 Stye Eye Relief (NDC 53799-305). 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

Conium maculatum 6X

Graphites 12X

Sulphur 12X

Purpose

redness

eyelid redness

tearing, burning

Uses:

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

  • redness
  • burning
  • eyelid redness
  • tearing

Warnings:

  • The purpose of this product is to provide temporary relief of stye symptoms, and is not a cure for styes.
  • For external use only.
  • 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.
  • 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
  • if condition is accompanied by fever

Stop Use And Ask A Doctor If:

  • you experience eye pain or changes in vision
  • symptoms worsen or persist for more than 72 hours
  • the stye enlarges
  • the style opens, draining discharge or pus into the eye

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 3-4 times per day
  • replace cap after use
  • if desired, use with a warm, moistened washcloth placed directly on eyelid

Other Information:

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

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

Questions?

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

Principal Display Panel


Similasan
Stye Eye Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz

Principal Display Panelsimilasanstye Eye Reliefsterile Eye Drops10 mL / 0.33 Fl Oz (Stye Eye Relief 01)

Principal Display Panelsimilasanstye Eye Reliefsterile Eye Drops10 mL / 0.33 Fl Oz (Stye Eye Relief 01)

* Please review the disclaimer below.