Label: INFANTS TEETHING LIQUID- 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 February 25, 2014

If you are a consumer or patient please visit this version.

  • 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

    Chamomilla (German chamomile) 5C .....................................................gum pain, restlessness, irritability and agitation

    Arnica montana (Leopard's bane) 5C ......................................................toothache and fever

    Borax (Sodium borate) 5C .....................................................................gum inflammation and diarrhea

    Hypericum perforatum (St.John's wort) 5C ..............................................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.

  • 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

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

  • Warnings

    Do not use if seal under bottle cap 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

    • Do not use more than directed.
    • Do not take with food.
    • Take 0.75 mL orally at the onset of pain.
    • Repeat every 15 minutes up to 4 times daily then reduce with improvement until pain subsides, or as directed by a healthcare professional.

    Age: Infants and children 0 to 9 years of age

    Dose: 0.75 mL

  • Other information

    Store at room temperature.

  • Inactive ingredients

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

  • REFERENCES

    RETAIN CARTON FOR COMPLETE INSTRUCTIONS

  • CARTON

    image of carton

  • INGREDIENTS AND APPEARANCE
    INFANTS TEETHING LIQUID 
    chamomilla, arnica montana, borax, hypericum perforatum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-642
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE5 [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:59779-642-021 in 1 CARTON
    125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/25/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-642)