Label: IRRITATED EYE RELIEF- atropa belladonna, euphrasia stricta and calcium sulfide 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 March 20, 2019

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  • 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 relieve:

    • 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.
    • 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 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 you are experiencing a think, white, yellow, or green discharge that forms a crust on the eyelid
    • if the solution changes color or becomes cloudy
    • if you experience eye pain or changes in vision
    • if you frequently contract infections that do not clear up easily
  • 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:

    • 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
  • Inactive ingredients:

    Phosphate buffer, Purified water

  • Prinicipal Display Panel

    HOMEOPATHIC
    NDC 59262-356-13
    Similasan
    Irritated
    Eye Relief
    sterile eye droppers
    0.45 ml / 0.015 fl oz each
    (0.9 ml / 0.03 fl oz total)

    HOMEOPATHIC NDC 59262-356-13 Similasan Irritated Eye Relief sterile eye droppers 0.45 ml / 0.015 fl oz each (0.9 ml / 0.03 fl oz total)

  • Prinicipal Display Panel

    SIMILASAN / USA
    30033
    Irritated Eye Relief, eye drops,
    Single-Use Droppers
    2 x 0.45 ml, Trial size buffered
    200 pieces (Stk.)
    Batch
    000000
    Exp.
    00/0000

    SIMILASAN / USA 30033 Irritated Eye Relief, eye drops, Single-Use Droppers 2 x 0.45 ml, Trial size buffered 200 pieces (Stk.) Batch 000000 Exp. 00/0000

  • INGREDIENTS AND APPEARANCE
    IRRITATED EYE RELIEF 
    atropa belladonna, euphrasia stricta and calcium sulfide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-356
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 0.45 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 0.45 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 0.45 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-356-01200 in 1 CARTON07/02/2013
    10.45 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:59262-356-130.45 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/02/201312/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/02/2013
    Labeler - Similasan Corporation (111566530)
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