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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated June 1, 2011

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  • 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:  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.                              

  • 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

  • INGREDIENTS AND APPEARANCE
    INJURY - RESCUE  
    aconitum nap., arnica, bellis , calendula , echinacea, gelsemium, hamamelis, hypericum , ledum, phosphorus, rhus toxicodendron, ruta, staphysag., symphytum, hydrastis liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus20 [hp_M]  in 1 mL
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana20 [hp_X]  in 1 mL
    Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY) Bellis Perennis20 [hp_X]  in 1 mL
    Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top20 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified20 [hp_X]  in 1 mL
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root20 [hp_X]  in 1 mL
    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 mL
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum20 [hp_X]  in 1 mL
    Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig20 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf20 [hp_X]  in 1 mL
    Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top20 [hp_X]  in 1 mL
    Delphinium Staphisagria Seed (UNII: 00543AP1JV) (Delphinium Staphisagria Seed - UNII:00543AP1JV) Delphinium Staphisagria Seed20 [hp_X]  in 1 mL
    Comfrey Root (UNII: M9VVZ08EKQ) (Comfrey Root - UNII:M9VVZ08EKQ) Comfrey Root20 [hp_X]  in 1 mL
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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)
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