IRRITATED EYE RELIEF (ATROPA BELLADONNA, CALCIUM SULFIDE AND EUPHRASIA STRICTA) SOLUTION/ DROPS [SIMILASAN CORPORATION]

IRRITATED EYE RELIEF (ATROPA BELLADONNA, CALCIUM SULFIDE AND EUPHRASIA STRICTA) SOLUTION/ DROPS [SIMILASAN CORPORATION]
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NDC 59262-348-11
Set ID d21830b0-7e9d-48df-9905-8058774c55ed
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

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

  • Purpose

    dryness, redness, burning, sensation of grittiness

  • Active Ingredient

    Euphrasia 6X

  • Purpose

    watery discharge

  • Active Ingredient

    Hepar sulphuris 12X

  • Purpose

    redness, stinging

  • Uses:

    According to homeopathic principles, the active ingredients in this medication help to temporarily relieve symptoms of:

    • redness of the eyes
    • excessive watery (clear) discharge
    • sensation of grittiness
    • irritation, dryness, and burning
  • Warnings:

    • For external use only.
    • Children under 2 years of age should be seen by a physician.
    • Initial exacerbation of symptoms may occur.
    • 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.
    • Replace cap tightly after every use.
    • 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
    • if you experience eye pain or changes in vision
  • Stop use and ask a doctor if:

    • symptoms worsen or persist for more than 72 hours
    • changes in vision occur
    • you might have a serious underlying medical cause for the infection
  • Directions:

    For adults and children ages 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.

  • 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

  • Prinicipal Display Panel

    NDC 59262-348-11
    Similasan
    Irritated Eye Relief
    STERILE EYE DROPS
    10 ml / 0.33 fl oz

    NDC 59262-348-11 Similasan Irritated Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    IRRITATED EYE RELIEF 
    atropa belladonna, calcium sulfide and euphrasia stricta solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-348
    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
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SILVER SULFATE (UNII: 8QG6HV4ZPO)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-348-1110 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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