Label: TEETHING KIDS RELIEF- chamomilla, arnica montana, borax, hypericum perforatum liquid

  • 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 April 3, 2014

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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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