Label: KIDS ALLERGY EYE RELIEF- apis and euphrasia and pulsatilla and sabadilla 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 October 7, 2020

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Apis 6X

  • Purpose

    burning, itching, swelling

  • Active Ingredient

    Euphrasia officinalis (Eyebright) 6X

  • Purpose

    redness, swelling, watering

  • Active Ingredient

    Pulsatilla 6X

  • Purpose

    itching, hay fever, watering, eye complaints in children

  • Active Ingredient

    Sabadilla 6X

  • Purpose

    watering, redness of lids

  • Uses:

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

    • itching
    • burning
    • redness of eyes and lids
    • excessive watering
  • 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 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:

    • the child experiences eye pain or changes in vision
    • symptoms worsen or persist for more than 72 hours
  • Directions:

    For children age 2 and over:

    • remove tamper-evident seal from neck of bottle
    • twist cap off bottle
    • DON’T squeeze bottle, squeeze plastic tip to release 1-2 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 sulphate (as preservative), Sodium nitrate

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL


    Similasan
    Kids Allergy Eye Relief
    STERILE EYE DROPS
    10 ml / 0.33 fl oz

    Similasan Kids Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    KIDS ALLERGY EYE RELIEF 
    apis and euphrasia and pulsatilla and sabadilla solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-500
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 0.45 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 0.45 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]  in 0.45 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 0.45 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SILVER SULFATE (UNII: 8QG6HV4ZPO)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53799-500-111 in 1 BOX09/28/2020
    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 homeopathic09/28/2020
    Labeler - Similasan AG (481545754)
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