BABYTEETH (ACONITUM NAPELLUS, BELLADONNA, BORAX, CALCAREA PHOSPHORICA, CHAMOMILLA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NITRICUM ACIDUM, STAPHYSAGRIA) LIQUID [VITAMED, LLC]

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  • BABYTEETH (ACONITUM NAPELLUS, BELLADONNA, BORAX, CALCAREA PHOSPHORICA, CHAMOMILLA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NITRICUM ACIDUM, STAPHYSAGRIA) LIQUID [VITAMED, LLC]

BABYTEETH (ACONITUM NAPELLUS, BELLADONNA, BORAX, CALCAREA PHOSPHORICA, CHAMOMILLA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NITRICUM ACIDUM, STAPHYSAGRIA) LIQUID [VITAMED, LLC]
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NDC 64249-0001-1, 64249-0001-2
Set ID d37b43d8-1d1b-49be-93c8-2436c4d1587f
Category HUMAN OTC DRUG LABEL
Packager VitaMed, LLC
Generic Name
Product Class
Product Number
Application Number
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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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