Label: BABYTEETH- aconitum napellus, belladonna, borax, calcarea phosphorica, chamomilla, kali phosphoricum, magnesia phosphorica, nitricum acidum, staphysagria 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 January 6, 2015

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  • ACTIVE INGREDIENTS:

    Aconitum Napellus 30C, Belladonna 30C, Borax 30C, Calcarea Phosphorica 8X, Chamomilla 3X, Kali Phosphoricum 6X, Magnesia Phosphorica 8X, Nitricum Acidum 30C, Staphysagria 9X

  • INDICATIONS:

    May temporarily relieve symptoms of teething: swelling, inflammation, pain.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the U.S. Food and Drug Administration.

  • WARNINGS:

    If symptoms persist, consult a doctor.

    If pregnant or breast-feeding, ask a doctor before use.

    Keep out of reach of children.  In case of overdose, get medical help or call a Poison Control Center right away.

    Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

  • DIRECTIONS:

    Apply 2 drops under the tongue, or on the affected gum area, for each year of age as needed, up to 6 times per day. Use one drop per dose for children under 1 year of age.

  • INDICATIONS:

    May temporarily relieve symptoms of teething: swelling, inflammation, pain.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the U.S. Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Glycerin 10% v/v, Organic alcohol 9% v/v, Purified water.

  • QUESTIONS:

    Manufactured for VitaMed, LLC, 311 S Division St.,

    Carson City, NV 89703. Phone number: (800) 270-7379

  • PACKAGE LABEL DISPLAY

    Vita Med

    BabyTeeth

    Teething

    HOMEOPATHIC

    1.0 FL OZ. (30 ml)

    Made in USA

    with U.S. and foreign components

    Babyteeth

    Babyteeth carton

  • INGREDIENTS AND APPEARANCE
    BABYTEETH 
    aconitum napellus, belladonna, borax, calcarea phosphorica, chamomilla, kali phosphoricum, magnesia phosphorica, nitricum acidum, staphysagria liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64249-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE30 [hp_C]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION8 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 1 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID30 [hp_C]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED9 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64249-0001-21 in 1 CARTON
    1NDC:64249-0001-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2014
    Labeler - VitaMed, LLC (079364194)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(64249-0001) , api manufacture(64249-0001) , label(64249-0001) , pack(64249-0001)
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