BABYTEETH- aconitum napellus, belladonna, borax, calcarea phosphorica, chamomilla, kali phosphoricum, magnesia phosphorica, nitricum acidum, staphysagria liquid 
VitaMed, LLC

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.

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DRUG FACTS:

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

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)

Revised: 1/2015
Document Id: 88024b84-c53c-4b58-984b-7f4a6412e3e6
Set id: d37b43d8-1d1b-49be-93c8-2436c4d1587f
Version: 2
Effective Time: 20150106
 
VitaMed, LLC