Fungal 4788l

Fungal 4788l
SPL v2
SPL
SPL Set ID 99487f4a-76f6-407b-e053-2a95a90acfd4
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (15 [hp_X]) Sulfur (6 [hp_X]) Sulfuric Acid (16 [hp_X]) Zinc Apis Mellifera Thuja Occidentalis Leafy Twig Candida Albicans Sanicula Europaea Leaf Tellurium Saccharomyces Cerevisiae Antimony Trisulfide Arsenic Cation (3+) Barium Cation Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude Activated Charcoal Copper Solanum Dulcamara Top Graphite Carbonate Ion Lachesis Muta Venom Lycopodium Clavatum Spore Daphne Mezereum Bark Nitric Acid Phosphorus Phytolacca Americana Root Sepia Officinalis Juice
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

Purpose

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.


Medication Information

Purpose

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

Description

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

Package Label.

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.

Questions Section

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

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.

Otc Active Ingredient Section

Equal parts of Apis mel. 6x, Phytolacca 6x, Thuja occ. 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Baryta carb. 15x, Bryonia 15x, Calc. carb.15x, Candida alb. 15x, Carbo veg. 15x, Cuprum met. 15x, Dulcamara 15x, Graphites 15x, Kali carb. 15x, Lachesis 15x, Lycopodium 15x, Mezereum 15x, Nitricum ac. 15x, Phos. 15x, Phytolacca 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Sulphuricum ac. 15x, Zinc. met. 15x, Sanicula 16x, Tellurium 16x, Torula cerevisiae 16x.

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.


Structured Label Content

Package Label. (PACKAGE LABEL.)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

Dosage & Administration Section (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.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Apis mel. 6x, Phytolacca 6x, Thuja occ. 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Baryta carb. 15x, Bryonia 15x, Calc. carb.15x, Candida alb. 15x, Carbo veg. 15x, Cuprum met. 15x, Dulcamara 15x, Graphites 15x, Kali carb. 15x, Lachesis 15x, Lycopodium 15x, Mezereum 15x, Nitricum ac. 15x, Phos. 15x, Phytolacca 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Sulphuricum ac. 15x, Zinc. met. 15x, Sanicula 16x, Tellurium 16x, Torula cerevisiae 16x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)