TEETHING KIDS RELIEF (CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM) LIQUID [HOMEOLAB USA INC]

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  • TEETHING KIDS RELIEF (CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM) LIQUID [HOMEOLAB USA INC]

TEETHING KIDS RELIEF (CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM) LIQUID [HOMEOLAB USA INC]
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NDC 60512-9060-8
Set ID 8d87055c-44b4-4fce-8616-c4fac11cf294
Category HUMAN OTC DRUG LABEL
Packager HOMEOLAB USA INC
Generic Name
Product Class
Product Number
Application Number
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  • Active Ingredients HPUS:

    Chamomilla (German chamomile) 5C

    Arnica montana (Leopard`s bane) 5C

    Borax (Sodium borate) 5C

    Hypericum perforatum ( St John's wort) 5C

  • Purpose

    Gum pain, restlessness, irritability and agitation

    Toothache and fever

    Gum inflammation and diarrhea

    Dental nerve pain

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

    *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

    RETAIN CARTON FOR COMPLETE INSTRUCTIONS

  • Uses

    This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething*:

    • gum inflammation

    • gum pain

    • fever

    • diarrhea

    • restlessness and irritability

  • Warnings



    Do not use if imprinted shrink seal neckband is broken or missing.

    Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

    Keep out of reach of children.

  • Directions

    Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

    Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.

    Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.

  • CARTON

    image of carton label

  • LABEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    TEETHING KIDS RELIEF 
    chamomilla, arnica montana, borax, hypericum perforatum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA5 [hp_C]  in 25 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA5 [hp_C]  in 25 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE5 [hp_C]  in 25 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM5 [hp_C]  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9060-81 in 1 CARTON
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2008
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-9060)
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