Redness And Itchy Eye Relief
FDA Label NDC 59262-363

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 Corporation for the product Redness And Itchy Eye Relief (NDC 59262-363). 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 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

Apis mellifica 6X 

Euphrasia officinalis (Eyebright) 6X

Pulsatilla 6X

Sabadilla 6X

Purpose

stinging, burning, itching

redness, irritation

itching, burning, redness, watering

watering, redness of lids

Uses:

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

  • itching            
  • burning
  • redness of eyes and lids      
  • stinging
  • excessive watering      
  • irritation

Warnings:

  • For external use only.
  • Initial exacerbation of symptoms may occur.
  • Replace cap tightly after every use.
  • To avoid contamination, do not touch the tip of the container to any surface.
  • Use within 30 days of opening. Expiration date only refers to unopened bottle.
  • Contact wearers: consult a physician prior to using.

If 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:

  • changes in vision occur
  • you experience eye pain
  • 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 2-3 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

Principal Display Panel

NDC 59262-363-11
Similasan®
Redness &
Itchy Eye
Relief
STERILE
EYE DROPS
10 mL/0.33 fl oz

Principal Display Panelndc 59262-363-11similasan®redness &itchy Eyereliefsterileeye Drops10 mL/0.33 Fl Oz (Redness And Itchy Eye Relief 01)

Principal Display Panelndc 59262-363-11similasan®redness &itchy Eyereliefsterileeye Drops10 mL/0.33 Fl Oz (Redness And Itchy Eye Relief 01)

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