Label: DRY EYE RELIEF- atropa belladonna and 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 February 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Belladonna† 6X

    Euphrasia officinalis (Eyebright) 6X

    Mercurius sublimatus 15X

  • Purpose

    dryness, redness

    redness

    dryness, watering

  • Uses*

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

    • dry eye

    • redness of eyes and lids

    • reflex watering secondary to dry eye

  • Warnings

    • For external use only.

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • Use only if single-use dropper is intact.

    • To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.

    • Contact lens 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 solution changes color or becomes cloudy

    Stop use and ask a doctor if:

    • symptoms worsen or persist for more than 72 hours

    • you experience eye pain or changes in vision

  • Directions

    For adults and children age 2 and over:

    • remove a single-use dropper

    • twist flat end with ball to remove

    • squeeze plastic dropper to release 2-3 drops into eye and discard applicator

    • apply as needed

    • use a new dropper for every application

  • Other Information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients

    Phosphate buffer, Purified water

  • Questions?

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

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-375-12
    Dry Eye
    Relief
    0.4 ml/0.014 fl oz each

    PRINCIPAL DISPLAY PANEL NDC 59262-375-12 Dry Eye Relief 0.4 ml/0.014 fl oz each

    PRINCIPAL DISPLAY PANEL NDC 59262-375-12 Dry Eye Relief 0.4 ml/0.014 fl oz each

  • INGREDIENTS AND APPEARANCE
    DRY EYE RELIEF 
    atropa belladonna and euphrasia stricta and mercuric chloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-375
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 0.4 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 0.4 mL
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE15 [hp_X]  in 0.4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-375-1220 in 1 CARTON03/01/2019
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2019
    Labeler - Similasan Corporation (111566530)
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