V-Fem Care: Homeopathic Product Information

V-FEM CARE- amanita muscaria fruiting body, arsenic trioxide, gold, berberis aquifolium root bark, dieffenbachia seguine, candida albicans, lytta vesicatoria, conium maculatum flowering top, graphite, chamaelirium luteum root, goldenseal, potassium carbonate, wood creosote, lycopodium clavatum spore, mercury, hexaplex trunculus hypobranchial gland juice, toxicodendron pubescens leaf, sodium chloride, nitric acid, anemone pulsatilla, sepia officinalis juice, sulfur, lycosa tarantula, thuja occidentalis leafy twig, zinc, apis mellifera and hamamelis virginiana root bark/stem bark liquid
Newton Laboratories, Inc.

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.

INDICATIONS & USAGE SECTION

Formulated for symptoms such as vaginal itching, burning, dryness and irritation.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 6 to 11, give 3 drops) as needed or as directed by a health professional.

OTC — ACTIVE INGREDIENT SECTION

Equal parts of Apis mellifica 11x, Hamamelis virginiana 11x, Hydrastis canadensis 11x, Agaricus muscarius 20x, Arsenicum album 20x, Aurum metallicum 20x, Berberis aquifolium 20x, Caladium seguinum 20x, Candida albicans 20x, Cantharis 20x, Conium maculatum 20x, Graphites 20x, Helonias dioica 20x, Hydrastis canadensis 20x, Kali carbonicum 20x, Kreosotum 20x, Lycopodium clavatum 20x, Mercurius vivus 20x, Murex purpurea 20x, Natrum muriaticum 20x, Nitricum acidum 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sepia 20x, Sulphur 20x, Tarentula hispana 20x, Thuja occidentalis 20x, Zincum metallicum 20x.

OTC — PURPOSE SECTION

Formulated for symptoms such as vaginal itching, burning, dryness and irritation.

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

V-FEM CARE agaricus musc., arsenicum alb., aur. met., berber. aqui., caladium seguinum, candida albicans, cantharis, conium, graphites, helonias dioica, hydrastis, kali carb., kreosotum, lycopodium, merc. viv., murex purpurea, nat. mur., nitricum ac., pulsatilla, rhus toxicodendron, sepia, sulphur, tarentula hispana, thuja occ., zinc. met., apis mel., hamamelis liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4823 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANITA MUSCARIA FRUITING BODY (AMANITA MUSCARIA FRUITING BODY) AMANITA MUSCARIA FRUITING BODY 20 [hp_X] in 1 mL ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 20 [hp_X] in 1 mL GOLD (GOLD) GOLD 20 [hp_X] in 1 mL BERBERIS AQUIFOLIUM ROOT BARK (BERBERIS AQUIFOLIUM ROOT BARK) BERBERIS AQUIFOLIUM ROOT BARK 20 [hp_X] in 1 mL DIEFFENBACHIA SEGUINE (DIEFFENBACHIA SEGUINE) DIEFFENBACHIA SEGUINE 20 [hp_X] in 1 mL CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 20 [hp_X] in 1 mL LYTTA VESICATORIA (LYTTA VESICATORIA) LYTTA VESICATORIA 20 [hp_X] in 1 mL CONIUM MACULATUM FLOWERING TOP (CONIUM MACULATUM FLOWERING TOP) CONIUM MACULATUM FLOWERING TOP 20 [hp_X] in 1 mL GRAPHITE (GRAPHITE) GRAPHITE 20 [hp_X] in 1 mL CHAMAELIRIUM LUTEUM ROOT (CHAMAELIRIUM LUTEUM ROOT) CHAMAELIRIUM LUTEUM ROOT 20 [hp_X] in 1 mL GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 20 [hp_X] in 1 mL POTASSIUM CARBONATE (CARBONATE ION) POTASSIUM CARBONATE 20 [hp_X] in 1 mL WOOD CREOSOTE (WOOD CREOSOTE) WOOD CREOSOTE 20 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 20 [hp_X] in 1 mL MERCURY (MERCURY) MERCURY 20 [hp_X] in 1 mL HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE (HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE) HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 20 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 20 [hp_X] in 1 mL SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 20 [hp_X] in 1 mL NITRIC ACID (NITRIC ACID) NITRIC ACID 20 [hp_X] in 1 mL ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 20 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 20 [hp_X] in 1 mL SULFUR (SULFUR) SULFUR 20 [hp_X] in 1 mL LYCOSA TARANTULA (LYCOSA TARANTULA) LYCOSA TARANTULA 20 [hp_X] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG) THUJA OCCIDENTALIS LEAFY TWIG 20 [hp_X] in 1 mL ZINC (ZINC) ZINC 20 [hp_X] in 1 mL APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 11 [hp_X] in 1 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 11 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55714-4823-1 30 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/02/2019

Labeler — Newton Laboratories, Inc. (788793610)

Registrant — Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Operations
Newton Laboratories, Inc.		788793610	manufacture (55714-4823)

Revised: 12/2020 Newton Laboratories, Inc.