Label: ALLERGY EYE RELIEF- apis mellifera, euphrasia stricta, schoenocaulon officinale seed 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 3, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Apis mellifica 6X

  • Purpose

    burning, itching, stinging

  • Active Ingredient

    Euphrasia officinalis (Eyebright) 6X

  • Purpose

    redness, swelling, watering

  • Active Ingredient

    Sabadilla 6X

  • Purpose

    watering, redness of lids

  • Uses:

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

    • itching      
    • burning
    • excessive watering
    • redness of eyes and lids
  • Warnings:

    • For external use only.
    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
    • Replace cap tightly after every use.
    • To avoid contamination, do not touch the plastic tip to any surface.
    • To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.
    • Contact 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 the 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 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 getinfo@similasanusa.com.

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-364-11

    Similasan

    Allergy Eye Relief

    STERILE EYE DROPS

    10 ml / 0.33 fl oz

    NDC 59262-364-11 Similasan Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    ALLERGY EYE RELIEF 
    apis mellifera, euphrasia stricta, schoenocaulon officinale seed solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-364
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 0.45 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 0.45 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 0.45 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SILVER SULFATE (UNII: 8QG6HV4ZPO)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-364-111 in 1 BOX04/13/2015
    110 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 homeopathic04/13/2015
    Labeler - Similasan Corporation (111566530)
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