COLD HANDS - FEET - histamine dihydrochloride, thyroid, unspecified, aconitum napellus, arsenic trioxide, bryonia alba root, selenicereus grandiflorus stem, calcium fluoride, ceanothus americanus leaf, cinchona officinalis bark, convallaria majalis, digitalis, gelsemium sempervirens root, nitroglycerin, centella asiatica, potassium carbonate, lachesis muta venom, naja naja venom, sodium carbonate, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, toxicodendron pubescens leaf, strophanthus hispidus seed, sulfur and echinacea, unspecified liquid 
Newton Laboratories, Inc.

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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Cold Hands - Feet  Formulated for symptoms associated with circulation such as dizziness, fatigue and weakness as well as tingling, numbness or coldness in the extremities.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Histaminum hydrochloricum 15x,Thyroidinum 15x, Aconitum nap. 10x, Arsenicum alb. 10x, Bryonia 10x, Cactus 10x, Calc. fluor. 10x, Ceanothus 10x, Cinchona 10x, Convallaria 10x, Digitalis 10x, Gelsemium 10x, Glonoinum 10x, Hydrocotyle 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nat. carb. 10x, Nat. mur. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Rhus toxicodendron 10x, Strophanthus hispidus 10x, Sulphur 10x, Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with circulation such as dizziness, fatigue and weakness as well as tingling, numbness or coldness in the extremities.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

COLD HANDS - FEET  
histaminum hydrochloricum,thyroidinum, aconitum nap., arsenicum alb., bryonia, cactus, calc. fluor., ceanothus, cinchona, convallaria, digitalis, gelsemium, glonoinum, hydrocoyle, kali carb., lachesis, naja, nat carb., nat mur., nux vom., phosphorus, pullsatilla, rhus toxicodendron, strophanthus hispidus, sulphur, echinacea liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2302
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Histamine Dihydrochloride (Histamine) Histamine Dihydrochloride15 [hp_X]  in 1 mL
Thyroid, Unspecified (Thyroid, Unspecified) Thyroid, Unspecified15 [hp_X]  in 1 mL
Aconitum Napellus (Aconitum Napellus) Aconitum Napellus10 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Selenicereus Grandiflorus Stem (Selenicereus Grandiflorus Stem) Selenicereus Grandiflorus Stem10 [hp_X]  in 1 mL
Calcium Fluoride (Fluoride Ion) Calcium Fluoride10 [hp_X]  in 1 mL
Ceanothus Americanus Leaf (Ceanothus Americanus Leaf) Ceanothus Americanus Leaf10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Convallaria Majalis (Convallaria Majalis) Convallaria Majalis10 [hp_X]  in 1 mL
Digitalis (Digitalis) Digitalis10 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root10 [hp_X]  in 1 mL
Nitroglycerin (Nitroglycerin) Nitroglycerin10 [hp_X]  in 1 mL
Centella Asiatica (Centella Asiatica) Centella Asiatica10 [hp_X]  in 1 mL
Potassium Carbonate (Carbonate Ion) Potassium Carbonate10 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom10 [hp_X]  in 1 mL
Naja Naja Venom (Naja Naja Venom) Naja Naja Venom10 [hp_X]  in 1 mL
Sodium Carbonate (Carbonate Ion) Sodium Carbonate10 [hp_X]  in 1 mL
Sodium Chloride (Chloride Ion) Sodium Chloride10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Strophanthus Hispidus Seed (Strophanthus Hispidus Seed) Strophanthus Hispidus Seed10 [hp_X]  in 1 mL
Sulfur (Sulfur) Sulfur10 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2302-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2302-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2302-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2302), API MANUFACTURE(55714-2302)

Revised: 03/2011
 
Newton Laboratories, Inc.