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 November 14, 2018

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  • Active Ingredient

    Belladonna* 6X

    *containing 0.000002% alkaloids calculated as hyoscyamine.

  • Purpose

    dryness, redness

  • Active Ingredient

    Euphrasia 6X

  • Purpose

    redness

  • Active Ingredient

    Mercurius sublimatus 6X

  • Purpose

    dryness

  • Uses

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

    • dry eye
    • redness of eyes and lids
    • reflex watering secondary to dry eye
    • sensation of grittiness
    • sensitivity to light
  • Warnings

    • For external use only.
    • 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.

    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.
    • changes in vision occur.
    • you experience eye pain.

    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.

  • 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
  • Inactive Ingredients

    Phosphate buffer, Purified water

  • Principal Display Panel

    NDC 59262-352-13
    Similasan
    Dry Eye
    Relief
    SINGLE-USE STERILE EYE DROPS
    Preservative Free
    0.4 ml/ 0.014 fl oz each
    NDC 59262-352-13 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz each


  • Principal Display Panel

    SIMILASAN / USA
    30011
    Dry Eye Relief, eye drops
    270 pieces(Stk)

    SIMILASAN / USA 30011 Dry Eye Relief, eye drops 270 pieces(Stk)
  • 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:59262-352
    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 CHLORIDE6 [hp_X]  in 0.4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-352-01270 in 1 CARTON07/02/2013
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:59262-352-13.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product07/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/02/2013
    Labeler - Similasan Corporation (111566530)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Packaging Inc071493142REPACK(59262-352)
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