Indications & Usage Section
FUNGAL INFECTION Formulated for symptoms associated with tinea versicolor, tinea corporis, tinea cruris, tinea pedis, onychomycosis and other fungal infections.
Fungal Infection
FDA Label NDC 55714-4618
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 Fungal Infection (NDC 55714-4618). 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, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Candida albicans 20x, Sanicula 20x, Tellurium metallicum 20x, Torula cerevisiae 20x, Antimon. crud. 15x, Arsenicum alb. 15x, Baryta carb. 15x, Bryonia 15x, Calc. carb. 15x, Carbo veg. 15x, Cuprum met. 15x, Dulcamara 15x, Graphites 15x, Kali carb. 15x, Lachesis 15x, Lycopodium 15x, Mezereum 15x, Nitricum ac. 15x, Phosphorus 15x, Phytolacca 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Sulphuricum ac. 15x, Zinc. met. 15x, Apis mel. 8x, Phytolacca 8x, Thuja 8x, Apis mel. 3x, Phytolacca 3x, Thuja 3x.
Purpose Section
Formulated for symptoms associated with tinea versicolor, tinea corporis, tinea cruris, tinea pedis, onychomycosis and other fungal infections.
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 (R123 L01)
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