INJURY RESCUE - aconitum napellus, arnica montana, 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, echinacea, unspecified, goldenseal, hypericum perforatum, comfrey root, echinacea, unspecified, goldenseal, hypericum perforatum and comfrey root liquid 
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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRODUCT NAME & INDICATIONS SECTION

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

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.                       

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

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 or 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

INJURY RESCUE  
aconitum nap., arnica, bellis , calendula , echinacea, gelsemium, hamamelis, hypericum , ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, echinacea, hydrastis, hypericum, symphytum, echinacea, hydrastis, hypericum, symphytum, organic cane dispensing alcohol liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4504
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aconitum Napellus (Aconitum Napellus) Aconitum Napellus20 [hp_M]  in 1 mL
Arnica Montana (Arnica Montana) Arnica Montana20 [hp_X]  in 1 mL
Bellis Perennis (Bellis Perennis) Bellis Perennis20 [hp_X]  in 1 mL
Calendula Officinalis Flowering Top (Calendula Officinalis Flowering Top) Calendula Officinalis Flowering Top20 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified20 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root20 [hp_X]  in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (Hamamelis Virginiana Root Bark/stem Bark) Hamamelis Virginiana Root Bark/stem Bark20 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum20 [hp_X]  in 1 mL
Ledum Palustre Twig (Ledum Palustre Twig) Ledum Palustre Twig20 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus20 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf20 [hp_X]  in 1 mL
Ruta Graveolens Flowering Top (Ruta Graveolens Flowering Top) Ruta Graveolens Flowering Top20 [hp_X]  in 1 mL
Delphinium Staphisagria Seed (Delphinium Staphisagria Seed) Delphinium Staphisagria Seed20 [hp_X]  in 1 mL
Comfrey Root (Comfrey Root) Comfrey Root20 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified8 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal8 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum8 [hp_X]  in 1 mL
Comfrey Root (Comfrey Root) Comfrey Root8 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal3 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum3 [hp_X]  in 1 mL
Comfrey Root (Comfrey Root) Comfrey Root3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-4504-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4504-259.14 mL 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(55714-4504), API MANUFACTURE(55714-4504)

Revised: 06/2011
Document Id: 8a1924ba-f766-a55a-f636-7bfa1e348fa9
Set id: 8568bf08-4d78-9c52-89ed-3772fec1dfee
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.