Label: DRY EYE NIGHTTIME- atropa belladonna, euphrasia stricta and mercuric chloride gel

  • 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, 2022

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Belladonna* 6X

  • Purpose

    dryness, redness

  • Active Ingredient

    Euphrasia officinalis (Eyebright) 6X

  • Purpose

    redness

  • Active Ingredient

    Mercurius sublimatus 15X

  • 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
  • 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 getinfo@similasanusa.com.
    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

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

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

  • INGREDIENTS AND APPEARANCE
    DRY EYE NIGHTTIME 
    atropa belladonna, euphrasia stricta and mercuric chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-378
    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 CHLORIDE15 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILVER SULFATE (UNII: 8QG6HV4ZPO)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-378-111 in 1 CARTON01/25/2022
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/25/2022
    Labeler - Similasan Corporation (111566530)
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