KIDS EARACHE RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]

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KIDS EARACHE RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN CORPORATION]
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NDC 59262-276-11
Set ID a3faf900-0d32-4566-8af2-b06da7512792
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    Drug Facts – Kids Earache Relief

  • Active ingredients

    Chamomilla 10X

    Mercurius solubilis 15X

    Pulsatilla 12X

    Sulphur 12X

  • Purpose

    sensitivity to drafts, soothing

    fullness, sensitivity to cold

    night time calmative

    itchiness, sensitivity to water

  • Uses*

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

    • sensation of fullness of the ear

    • sensitivity to cold, drafts, and water

    • the annoyance of water-clogged ears by helping clear water trapped in the ear

  • Warnings

    Do not use

    • in the eyes.

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

    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.

    Stop use and ask a doctor if:

    • symptoms persist for more than 48 hours

    • there is discharge from the ear

    • there is a fever of 102°F or greater

    Ask a doctor before use if the child has:

    • ear drainage or discharge

    • pain, irritation, or rash in the ear

    • had ear surgery

    • dizziness

  • Directions

    FOR USE IN THE EAR ONLY.

    For children ages 2 and over:

    • Remove tamper-evident seal from neck of bottle.

    • Twist cap off bottle.

    • Tilt child’s head sideways.

    • DON'T squeeze bottle, squeeze plastic tip to release 4-5 drops into ear (tip of applicator should not enter ear canal).

    • Keep drops in ear for 3-5 minutes by keeping head tilted or placing cotton in ear. Any excess drops can be wiped away from outer ear.

    • Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.

  • Other information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive ingredient

    Vegetable glycerin

  • Questions?

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

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-276-11
    Similasan
    Kids 
    Earache
    Relief
    EAR DROPS
    10 ml / 0.33 fl oz

    Text, calendar Description automatically generated

    Diagram Description automatically generated

  • INGREDIENTS AND APPEARANCE
    KIDS EARACHE RELIEF 
    matricaria recutita, mercurius solubilis, anemone patens and sulphur solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-276
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA10 [hp_X]  in 10 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS15 [hp_X]  in 10 mL
    PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE12 [hp_X]  in 10 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-276-111 in 1 BOX07/20/2018
    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 homeopathic07/20/2018
    Labeler - Similasan Corporation (111566530)
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