Label: JUST IN CASE- aconitum napellus, arnica montana, bryonia, echinacea, ledum palustre, arsenicum album, cenchris contortrix, crotalus cascavella, crotalus horridus, lachesis mutus, mercurius corrosivus, naja tripudians, phosphorus, toxicophis pugnax, vipera berus, elaps corallinus, heloderma. liquid

  • NDC Code(s): 55714-2561-1
  • Packager: Newton Laboratories, Inc.
  • Category: HUMAN OTC 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 March 6, 2020

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  • INDICATIONS & USAGE SECTION

    Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: For use as an interim therapy. Seek professional medical intervention for severe injuries, bites or infections.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Aconitum napellus 10x, Arnica montana 10x, Bryonia 10x, Echinacea 10x, Ledum palustre 10x, Arsenicum album 15x, Cenchris contortrix 15x, Crotalus cascavella 15x, Crotalus horridus 15x, Lachesis mutus 15x, Mercurius corrosivus 15x, Naja tripudians 15x, Phosphorus 15x, Toxicophis pugnax 15x, Vipera berus 15x, Elaps corallinus 30x, Heloderma 30x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

  • INACTIVE INGREDIENT SECTION

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

  • QUESTIONS SECTION

    newtonlabs.net – Questions? 800.448.7256

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

  • WARNINGS SECTION

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

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    JUST IN CASE 
    aconitum napellus, arnica montana, bryonia, echinacea, ledum palustre, arsenicum album, cenchris contortrix, crotalus cascavella, crotalus horridus, lachesis mutus, mercurius corrosivus, naja tripudians, phosphorus, toxicophis pugnax, vipera berus, elaps corallinus, heloderma. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2561
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 1 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED10 [hp_X]  in 1 mL
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG10 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
    AGKISTRODON CONTORTRIX VENOM (UNII: 3BKX485ZP0) (AGKISTRODON CONTORTRIX VENOM - UNII:3BKX485ZP0) AGKISTRODON CONTORTRIX VENOM15 [hp_X]  in 1 mL
    CROTALUS DURISSUS TERRIFICUS VENOM (UNII: 2XF6I0446G) (CROTALUS DURISSUS TERRIFICUS VENOM - UNII:2XF6I0446G) CROTALUS DURISSUS TERRIFICUS VENOM15 [hp_X]  in 1 mL
    CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956) CROTALUS HORRIDUS HORRIDUS VENOM15 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 1 mL
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE15 [hp_X]  in 1 mL
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM15 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
    AGKISTRODON PISCIVORUS VENOM (UNII: X9V1Q8U150) (AGKISTRODON PISCIVORUS VENOM - UNII:X9V1Q8U150) AGKISTRODON PISCIVORUS VENOM15 [hp_X]  in 1 mL
    VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M) VIPERA BERUS VENOM15 [hp_X]  in 1 mL
    MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980) MICRURUS CORALLINUS VENOM30 [hp_X]  in 1 mL
    HELODERMA HORRIDUM VENOM (UNII: O9M1UQ4YIO) (HELODERMA HORRIDUM VENOM - UNII:O9M1UQ4YIO) HELODERMA HORRIDUM VENOM30 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2561-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/02/2020
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2561)
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