BANGS SCRAPES - aconitum nap., arnica, bellis, calendula, echinacea, gelsemium, hamamelis, hypericum, ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis pellet 
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.

----------

Bangs - Scrapes

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 - 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.  

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

BANGS SCRAPES  
aconitum nap., arnica, bellis, calendula, echinacea, gelsemium, hamamelis, hypericum, ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1712
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus15 [hp_X]  in 1 g
Arnica Montana Root (UNII: MUE8Y11327) (Arnica Montana Root - UNII:MUE8Y11327) Arnica Montana Root15 [hp_X]  in 1 g
Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY) Bellis Perennis15 [hp_X]  in 1 g
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top15 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified15 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 g
Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark15 [hp_X]  in 1 g
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 g
Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig15 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 g
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top15 [hp_X]  in 1 g
Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed15 [hp_X]  in 1 g
Comfrey Root (UNII: M9VVZ08EKQ) (Comfrey Root - UNII:M9VVZ08EKQ) Comfrey Root15 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-1712-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-1712-256.7 g in 1 BOTTLE, GLASS
3NDC:55714-1712-07.08 g 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(55714-1712)

Revised: 3/2011
Document Id: 685ecea9-1343-6eb1-682a-740a80469f59
Set id: 0a445cd7-76b8-5228-1e77-a8b821792c60
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.