ACCIDENT - 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 and goldenseal 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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INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Arnica 15x, Bellis 15x, 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, 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

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

ACCIDENT - INJURY RESCUE
aconitum nap, arnica, bellis, calendula, echinacea, gelsemium, hamamelis, hypericum, ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis canadensis. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2266
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aconitum Napellus (Aconitum Napellus)	Aconitum Napellus	15 [hp_X] in 1 mL
Arnica Montana (Arnica Montana)	Arnica Montana	15 [hp_X] in 1 mL
Bellis Perennis (Bellis Perennis)	Bellis Perennis	15 [hp_X] in 1 mL
Calendula Officinalis Flowering Top (Calendula Officinalis Flowering Top)	Calendula Officinalis Flowering Top	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (Hamamelis Virginiana Root Bark/stem Bark)	Hamamelis Virginiana Root Bark/stem Bark	15 [hp_X] in 1 mL
Hypericum Perforatum (Hypericum Perforatum)	Hypericum Perforatum	15 [hp_X] in 1 mL
Ledum Palustre Twig (Ledum Palustre Twig)	Ledum Palustre Twig	15 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Ruta Graveolens Flowering Top (Ruta Graveolens Flowering Top)	Ruta Graveolens Flowering Top	15 [hp_X] in 1 mL
Delphinium Staphisagria Seed (Delphinium Staphisagria Seed)	Delphinium Staphisagria Seed	15 [hp_X] in 1 mL
Comfrey Root (Comfrey Root)	Comfrey Root	15 [hp_X] in 1 mL
Goldenseal (Goldenseal)	Goldenseal	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2266-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2266-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2266-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2266), API MANUFACTURE(55714-2266)

Revised: 03/2011

Document Id: 94c3712b-2c26-0c6d-da64-6035a0ad5f4c

Set id: 5e71e2ce-18d7-b298-838f-68d4c1420adf

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.