Label: PINK EYE NIGHTTIME- belladonna, euphrasia officinalis, hepar sulphuris 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 November 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Belladonna 6X†

    †containing 0.000002% alkaloids calculated as hyoscyamine

  • Purpose

    dryness, redness, burning, sensation of grittiness

  • Active ingredients

    Euphrasia officinalis (Eyebright) 6X

  • Purpose

    watery discharge

  • Active ingredients

    Hepar sulphuris 12X

  • Purpose

    redness, stinging

  • Uses*

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

    • excessive watery (clear) discharge

    • sensation of grittiness

    • redness and burning

  • Warnings

    • For external use only.

    • 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 bottle 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 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 solution 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

    • you might have a serious underlying medical cause for an infection

  • Directions

    For adults and children ages 2 and over:

    • remove tamper-evident seal from neck of bottle

    • twist cap off bottle

    • DON’T squeeze bottle, squeeze plastic tip to release 1-2 drops into eye

    • apply as needed

    • replace cap after use

  • Other information

    • Active ingredients are manufactured according to homeopathic principles.

    • Store below 86°F

  • Inactive ingredients

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

  • Questions?

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

    For your protection do not use if tamper evident seal around neck of bottle is missing or broken.

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-377-11
    Similasan
    Pink eye

    Nighttime
    Gel™
    10 mL/ 0.33 fl oz

    NDC 59262-377-11 Similasan Pink eye Nighttime Gel™ 10 mL/ 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    PINK EYE NIGHTTIME 
    belladonna, euphrasia officinalis, hepar sulphuris gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-377
    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
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [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:59262-377-111 in 1 CARTON11/09/2020
    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 homeopathic11/09/2020
    Labeler - Similasan Corporation (111566530)
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