Label: DRY EYE RELIEF- atropa belladonna, euphrasia stricta and mercuric chloride solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 20, 2011

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  • Active Ingredient

    Belladonna* 6X
    *containing 0.000002% alkaloids calculated as hyoscyamine

  • Purpose

    dryness, redness

  • Active Ingredient

    Euphrasia 6X

  • Purpose

    redness

  • Active Ingredient

    Mercurius sublimatus 6X

  • Purpose

    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
    • sensation of grittiness
    • sensitivity to light
  • 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:

    • symptoms worsen or persist for more than 72 hours
    • changes in vision occur
    • you experience eye pain
  • Directions:

    For adults and children age 2 and over:

    • remove tamper-evident seal from neck of bottle
    • twist cap off 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 and are therefore non-toxic and have no known side effects

  • Inactive Ingredients

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

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.
    www.SimilasanUSA.com

  • Principle Display Panel

    NDC 59262-345-11
    Similasan
    Dry Eye Relief
    Sterile Eye Drops
    10 ml / 0.33 fl oz

    NDC 59262-345-11 Similasan Dry Eye Relief Sterile Eye Drops 10 ml / 0.33 fl oz


  • INGREDIENTS AND APPEARANCE
    DRY EYE RELIEF 
    atropa belladonna, euphrasia stricta and mercuric chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-345
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 10 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 10 mL
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SILVER SULFATE (UNII: 8QG6HV4ZPO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-345-1110 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/02/2013
    Labeler - Similasan Corporation (111566530)
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