Label: DRY EYE RELIEF TRIAL SIZE 15X- belladonna, euphrasia officinalis, mercurius sublimatus, 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 July 12, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Dry Eye Relief Trial Size

  • Active Ingredient

    Belladonna* 6X

    *containing 0.000002% alkaloids calculated as hyoscyamine.

  • Purpose

    dryness, redness

  • Active Ingredient

    Euphrasia officinalis (Eyebright) 6X

  • Purpose

    redness

  • Active Ingredient

    Mercurius sublimatus 15X

  • Purpose

    dryness, watering

  • Uses*

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

    • dry eye
    • redness of eyes and lids
    • reflex watering secondary to dry eye
  • Warnings

    • For external use only.
    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
    • 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, 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:

    • twist flat end with ball to open
    • squeeze plastic dropper to release 2-3 drops into eye and discard applicator
    • apply as needed
  • Inactive Ingredients

    Phosphate buffer, Purified water

  • Principal Display Panel


    Similasan
    Dry Eye
    Relief
    SINGLE-USE STERILE EYE DROPS
    Preservative Free
    0.4 ml/ 0.014 fl oz (one vial)


    Principal Display Panel

Similasan
Dry Eye 
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz (one vial)
    Principal Display Panel

Similasan
Dry Eye 
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz (one vial)
    Principal Display Panel

Similasan
Dry Eye 
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz (one vial)
  • INGREDIENTS AND APPEARANCE
    DRY EYE RELIEF TRIAL SIZE 15X 
    belladonna, euphrasia officinalis, mercurius sublimatus, solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-376
    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
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CATION15 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53799-376-13.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product07/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/08/2021
    Labeler - Similasan AG (481545754)