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

IRRITATED EYE RELIEF (ATROPA BELLADONNA, EUPHRASIA STRICTA AND CALCIUM SULFIDE) SOLUTION/ DROPS [SIMILASAN CORPORATION]
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NDC 59262-356-01, 59262-356-13
Set ID fc56460f-2300-43c7-a4e2-a625e0245069
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 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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