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 
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.

----------

V-Fem 4823L

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4823
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY20 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE20 [hp_X]  in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD20 [hp_X]  in 1 mL
BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) BERBERIS AQUIFOLIUM ROOT BARK20 [hp_X]  in 1 mL
DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE20 [hp_X]  in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS20 [hp_X]  in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA20 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP20 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE20 [hp_X]  in 1 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT20 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL20 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE20 [hp_X]  in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE20 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE20 [hp_X]  in 1 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY20 [hp_X]  in 1 mL
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE (UNII: IQV54TN60Y) (HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - UNII:IQV54TN60Y) HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE20 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF20 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE20 [hp_X]  in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID20 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA20 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE20 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR20 [hp_X]  in 1 mL
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA20 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG20 [hp_X]  in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC20 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA11 [hp_X]  in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK11 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4823-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/02/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4823)

Revised: 12/2020
Document Id: b5e5161c-36db-aa11-e053-2995a90a4241
Set id: 999a6a72-4a8c-2c09-e053-2a95a90a0206
Version: 2
Effective Time: 20201207
 
Newton Laboratories, Inc.