Bangs - Scrapes

Bangs - Scrapes
SPL v1
SPL
SPL Set ID 0a445cd7-76b8-5228-1e77-a8b821792c60
Route
ORAL
Published
Effective Date 2012-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (15 [hp_X]) Arnica Montana Root (3 [hp_X]) Bellis Perennis Calendula Officinalis Flowering Top Echinacea, Unspecified Gelsemium Sempervirens Root Hamamelis Virginiana Root Bark/stem Bark Hypericum Perforatum Ledum Palustre Twig Phosphorus Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Delphinium Staphisagria Seed Comfrey Root Goldenseal
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Bangs - Scrapes  Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.

Purpose

Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.


Medication Information

Purpose

Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.

Description

Bangs - Scrapes  Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.

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.  

Questions Section

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

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.  

Indications & Usage Section

Bangs - Scrapes  Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.

Dosage & Administration Section

Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Unde age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Aconitum nap. 15x, Arnica 15x, Bellis15x, Calendula 15x, Echinacea 15x, Gelsemium 15x, Hamamelis 15x, Hypericum 15x, Ledum 15x, Phosphorus 15x, Rhus toxicodendron 15x, Ruta 15x, Staphysag. 15x, Symphytum 15x, Echinacea 3x, Hydrastis 3x, Hypericum 3x, Symphytum 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.  

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.  

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Bangs - Scrapes  Formulated for symptoms associated with injury, medical procedures or shock such as pain, emotional upset, inflammation, trauma and bruising.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions:  Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) as needed or as directed by a healthcare professional. Unde age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Aconitum nap. 15x, Arnica 15x, Bellis15x, Calendula 15x, Echinacea 15x, Gelsemium 15x, Hamamelis 15x, Hypericum 15x, Ledum 15x, Phosphorus 15x, Rhus toxicodendron 15x, Ruta 15x, Staphysag. 15x, Symphytum 15x, Echinacea 3x, Hydrastis 3x, Hypericum 3x, Symphytum 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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