ACCIDENT - INJURY RESCUE- aconitum nap, arnica, bellis, calendula, echinacea, gelsemium, hamamelis, hypericum, ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis canadensis. 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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Accident N034-2381P

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

WARNINGS SECTION

Warning:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for mre than a few days, consult a doctor. If breast-feeding, ask a doctor before use.

QUESTIONS

www.newtonlabs.net~ Questions? 800-448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

OTC - PURPOSE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hydrastis 6x, Hypericum 6x, Symphytum 6x, Aconitum nap. 15x, Arnica 15x, Bellis 15x, Calendula 15x, Echinacea 15x, Gelsemium 15x, Hamamelis 15x, Hypericum 15x, Ledum 15x, Phos. 15x, Rhus tox. 15x, Ruta 15x, Staphysag. 15x, Symphytum 15x.

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL

package label

ACCIDENT - INJURY RESCUE 
aconitum nap, arnica, bellis, calendula, echinacea, gelsemium, hamamelis, hypericum, ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis canadensis. pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2381
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 (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA15 [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) GOLDENSEAL6 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2381-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/17/201811/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/17/201811/23/2021
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2381)

Revised: 11/2021
Document Id: d17c3b79-6990-3f02-e053-2995a90ae7aa
Set id: 7874aaf3-d289-010d-e053-2a91aa0ae5e4
Version: 3
Effective Time: 20211123
 
Newton Laboratories, Inc.