INJURY - RESCUE - 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.

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Injury - Rescue

INDICATIONS & USAGE SECTION

Injury - Rescue  Formulated for symptoms associated with injury, trauma or surgery such as pain, shock, emotional upset, bruising and inflammation.                               

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.                       

ACTIVE INGREDIENT SECTION

Aconitum nap. 20x,  Arnica 20x, Bellis  20x, Calendula  20x, Echinacea 20x, Gelsemium 20x, Hamamelis 20x, Hypericum  20x, Ledum 20x, Phosphorus 20x, Rhus toxicodendron 20x, Ruta 20x, Staphysag. 20x, Symphytum 20x, Echinacea 8x, Hydrastis 8x, Hypericum 8x, Symphytum 8x, Echinacea 3x, Hydrastis 3x, Hypericum 3x, Symphytum 3x.             

PURPOSE SECTION

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

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.                              

PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.                      

PACKAGE LABEL

package label

INJURY - RESCUE  
aconitum nap., arnica, bellis , calendula , echinacea, gelsemium, hamamelis, hypericum , ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis pellet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4505
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus20 [hp_X]  in 1 g
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana20 [hp_X]  in 1 g
Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY) Bellis Perennis20 [hp_X]  in 1 g
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top20 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified20 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [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 Bark20 [hp_X]  in 1 g
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum20 [hp_X]  in 1 g
Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig20 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf20 [hp_X]  in 1 g
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top20 [hp_X]  in 1 g
Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed20 [hp_X]  in 1 g
Comfrey Root (UNII: M9VVZ08EKQ) (Comfrey Root - UNII:M9VVZ08EKQ) Comfrey Root20 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal8 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4505-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-4505-256.7 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4505)

Revised: 6/2011
Document Id: 3d30e6a0-3f7a-9434-453e-8d4898fba03c
Set id: c3760d58-05f0-973d-f5e8-6f672eb82e73
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.