Label: CHILDRENS PINK EYE RELIEF- atropa belladonna, calcium sulfide, euphrasia stricta and platycladus orientalis leaf solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 30, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts – Children’s Pink Eye Relief

  • Active ingredients

    Belladonna 6X†

    Euphrasia officinalis (Eyebright) 6X

    Hepar sulphuris 12X

    Thuja 15X

  • Purpose

    dryness, redness, burning

    redness, burning, watering

    sensation of grittiness, stinging

    irritation

  • Uses*

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

    • redness of the eyes

    • irritation, dryness, and burning

    • sensation of grittiness

    • excessive watering (clear)

  • Warnings

    • For external use only.

    • Children under 2 years of age should be seen by a physician.

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • To avoid contamination do not touch the tip of the bottle to any surface.

    • To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.

    • Contact wearers: consult 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:

    • the child experiences eye pain or changes in vision

    • symptoms worsen or persist for more than 72 hours

  • Directions

    For children ages 2 and over:

    • remove tamper-evident seal from neck of bottle

    • twist cap off bottle

    • DON'T squeeze bottle, squeeze plastic tip to release 1 to 2 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 sulfate (as preservative), Sodium nitrate

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

    www.SimilasanUSA.com

    †containing 0.000002% alkaloids calculated as hyoscyamine

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-369-11
    Similasan
    Children’s
    Pink Eye
    Relief
    STERILE EYE DROPS
    10 ml / 0.33 fl oz

    NDC 59262-369-11
Similasan
Children’s 
Pink Eye
Relief
STERILE EYE DROPS
10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PINK EYE RELIEF 
    atropa belladonna, calcium sulfide, euphrasia stricta and platycladus orientalis leaf solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-369
    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
    PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B) (PLATYCLADUS ORIENTALIS LEAF - UNII:32E5V7G32B) PLATYCLADUS ORIENTALIS LEAF15 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILVER SULFATE (UNII: 8QG6HV4ZPO)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-369-111 in 1 CARTON03/01/2019
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC03/01/2019
    Labeler - Similasan Corporation (111566530)