FDA.reportPublic FDA data

Just In Case

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:57

Label at a glance#

ProductJust In Case
Active ingredientBRYONIA ALBA ROOT, ECHINACEA, UNSPECIFIED, RHODODENDRON TOMENTOSUM LEAFY TWIG, ARSENIC TRIOXIDE, AGKISTRODON CONTORTRIX VENOM, CROTALUS DURISSUS TERRIFICUS VENOM, CROTALUS HORRIDUS HORRIDUS VENOM, ACONITUM NAPELLUS, MERCURIC CHLORIDE, NAJA NAJA VENOM, PHOSPHORUS, AGKISTRODON PISCIVORUS VENOM, VIPERA BERUS VENOM, MICRURUS CORALLINUS VENOM, HELODERMA HORRIDUM VENOM, ARNICA MONTANA, LACHESIS MUTA VENOM
Label structure10 sections

Label contents#

Full prescribing information#

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

OTC - 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.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2561-1Just In Case30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2561JUST 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 [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250212_a035f2bf-2f5d-0a50-e053-2995a90a8d9c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-256155714-2561-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BRYONIA ALBA ROOTT7J046YI2BACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
AGKISTRODON CONTORTRIX VENOM3BKX485ZP0ACTIB
CROTALUS DURISSUS TERRIFICUS VENOM2XF6I0446GACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
PHOSPHORUS27YLU75U4WACTIB
AGKISTRODON PISCIVORUS VENOMX9V1Q8U150ACTIB
VIPERA BERUS VENOM0ORO6NCA4MACTIB
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
HELODERMA HORRIDUM VENOMO9M1UQ4YIOACTIB
ARNICA MONTANAO80TY208ZWACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Just In CaseACONITUM 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.Newton Laboratories, Inc.a035f2bf-2f5d-0a50-e053-2995a90a8d9c2025-02-10WarningsExact identifier
ndc (package): 55714-2561-1
ndc (product): 55714-2561
ndc11 (package): 55714256101
spl id: 2dd1fcbd-6eb5-f727-e063-6294a90a24c7
spl set id: a035f2bf-2f5d-0a50-e053-2995a90a8d9c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.