Cold Hands 2404l

Cold Hands 2404l
SPL v3
SPL
SPL Set ID 7a2b4f28-2128-a8b2-e053-2a91aa0a2402
Route
ORAL
Published
Effective Date 2018-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Histamine (15 [hp_X]) Thyroid, Unspecified (6 [hp_X]) Aconitum Napellus Arsenic Cation (3+) Bryonia Alba Root Selenicereus Grandiflorus Stem Fluoride Ion Ceanothus Americanus Leaf Cinchona Officinalis Bark Convallaria Majalis Digitalis Gelsemium Sempervirens Root Nitroglycerin Centella Asiatica Carbonate Ion Lachesis Muta Venom Naja Naja Venom Chloride Ion Strychnos Nux-vomica Seed Phosphorus Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Strophanthus Hispidus Seed Sulfur Echinacea, Unspecified
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-11-08 Until 2019-08-01

Description

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Purpose

Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.


Medication Information

Purpose

Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.

Description

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net - Questions? 800 448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.

Inactive Ingredient Section

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.

Dosage & Administration Section

Adults, take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Aconitum nap. 15x, Arsenicum alb. 15x, Bryonia 15x, Cactus 15, Calc. fluor. 15x, Ceanothus 15x, Cinchona 15x, Convallaria 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Histaminum hydrochloricum 15x, Hydrocotyle 15x, Kali carb. 15x, Lachesis 15x, Naja 15x, Nat. carb. 15x, Nat. mur. 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Strophanthus hisp. 15x, Sulphur 15x, Thyroidinum 15x.

Otc Pregnancy Or Breast Feeding Section

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

Otc Keep Out of Reach of Children Section

Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800 448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as dizziness, fatigue, weakness, tingling and numb or cold extremities.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Adults, take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Aconitum nap. 15x, Arsenicum alb. 15x, Bryonia 15x, Cactus 15, Calc. fluor. 15x, Ceanothus 15x, Cinchona 15x, Convallaria 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Histaminum hydrochloricum 15x, Hydrocotyle 15x, Kali carb. 15x, Lachesis 15x, Naja 15x, Nat. carb. 15x, Nat. mur. 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Strophanthus hisp. 15x, Sulphur 15x, Thyroidinum 15x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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