Label: CHILDRENS ALLERGY EYE RELIEF- anemone patens, apis mellifera, euphrasia stricta and schoenocaulon officinale seed 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

    Drug Facts – Children’s Allergy Eye Relief

  • Active Ingredients

    Apis 6X      

    Euphrasia officinalis (Eyebright) 6X

    Pulsatilla 6X

    Sabadilla 6X

  • Purpose

    burning, itching, swelling

    redness, swelling, watering

    itching, hay fever, watering, eye complaints in children

    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 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

  • PRINCIPAL DISPLAY PANEL


    Similasan
    Children’s
    Allergy
    Eye Relief
    STERILE EYE DROPS
    10 ml / 0.33 fl oz

    Similasan Children’s Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY EYE RELIEF 
    anemone patens, apis mellifera, euphrasia stricta and schoenocaulon officinale seed solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53799-370
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 10 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 10 mL
    PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE6 [hp_X]  in 10 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [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:53799-370-111 in 1 CARTON10/02/2020
    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 HOMEOPATHIC10/02/2020
    Labeler - Similasan AG (481545754)
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