Pain Soother

Pain Soother
SPL v1
SPL
SPL Set ID 52c53def-472e-d802-6515-cfb9a2fc39de
Route
ORAL
Published
Effective Date 2012-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (15 [hp_X]) Silver Cation (3 [hp_X]) Arnica Montana Bryonia Alba Root Colchicum Autumnale Bulb Guaiac Hypericum Perforatum Kalmia Latifolia Leaf Phosphorus Phytolacca Americana Root Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Lactic Acid, L- Lobaria Pulmonaria Datura Stramonium Hamamelis Virginiana Root Bark/stem Bark Taraxacum Officinale
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-04-15

Description

Pain Soother   Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Purpose

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.


Medication Information

Purpose

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Description

Pain Soother   Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Package Label

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 Purpose Section

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Otc Questions Section

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

Questions?  1.800.448.7256 

Inactive Ingredient Section

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

Indications & Usage section

Pain Soother   Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Dosage & Administration Section

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia latifolia 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Rhus tox. 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 15x, Hamamelis 3x, Phytolacca 3x, Ruta 3x, Taraxacum 3x.

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.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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 Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Otc Questions Section (OTC - QUESTIONS SECTION)

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

Questions?  1.800.448.7256 

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage section (INDICATIONS & USAGE SECTION)

Pain Soother   Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia latifolia 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Rhus tox. 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 15x, Hamamelis 3x, Phytolacca 3x, Ruta 3x, Taraxacum 3x.

Otc Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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