FDA.reportPublic FDA data

V-Fem Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:26

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Hamamelis 6x, Hydrastis 6x, Agaricus musc. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Caladium seguinum 15x, Candida alb. 15x, Cantharis 15x, Conium 15x, Graphites 15x, Helonias 15x, Hydrastis 15x, Kali carb. 15x, Kreosotum 15x, Lycopodium 15x, Merc. viv. 15x, Murex 15x, Nat. mur. 15x, Nitricum ac. 15x, Pulsatilla 15x, Rhus tox. 15x, Sepia 15x, Sulphur 15x, Tarentula hisp. 15x, Thuja oc. 15x, Zinc. met. 15x.

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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.

Directions And Dosage

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.

Other Label Information

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

PACKAGE LABEL

Label Images#

R044-L01
R044-L01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4856-1V-Fem Care30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4856V-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.]1Current NDC, 1 package rows20240327_14800c19-e5c6-924b-e063-6394a90a15e5.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-485655714-4856-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
ALCOHOL3K9958V90MIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
GOLD79Y1949PYOACTIB
BERBERIS AQUIFOLIUM ROOT BARKVZJ9F3C3SBACTIB
WATER059QF0KO0RIACT
DIEFFENBACHIA SEGUINE01800C6E6BACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
GRAPHITE4QQN74LH4OACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURYFXS1BY2PGLACTIB
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICEIQV54TN60YACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
NITRIC ACID411VRN1TV4ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
LYCOSA TARANTULA86M454L2TTACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ZINCJ41CSQ7QDSACTIB
APIS MELLIFERA7S82P3R43ZACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Hamamelis 6x, Hydrastis 6x, Agaricus musc. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Caladium seguinum 15x, Candida alb. 15x, Cantharis 15x, Conium 15x, Graphites 15x, Helonias 15x, Hydrastis 15x, Kali carb. 15x, Kreosotum 15x, Lycopodium 15x, Merc. viv. 15x, Murex 15x, Nat. mur. 15x, Nitricum ac. 15x, Pulsatilla 15x, Rhus tox. 15x, Sepia 15x, Sulphur 15x, Tarentula hisp. 15x, Thuja oc. 15x, Zinc. met. 15x.

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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.

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.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML