Just In Case
FDA Label NDC 55714-8016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Just In Case (NDC 55714-8016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications & Usage Section

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

Aconitum nap. 10x, Arnica 10x, Arsenicum alb. 10x, Bryonia 10x, Echinacea 10x, Ledum 10x, Cenchris 15x, Crotalus casc. 15x, Crotalus hor. 15x, Lachesis 15x, Merc. corros. 15x, Naja 15x, Phos. 15x, Toxicophis 15x, Vipera 15x, Elaps cor. 30x, Heloderma 30x.

Otc - Purpose Section

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

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:  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 (Ss14 L01)

Package Label (Ss14 L01)

* Please review the disclaimer below.