Vaginitis - Feminine Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:26

Label at a glance#

ProductVaginitis - Feminine Care
Active ingredientAmanita Muscaria Var. Muscaria Fruiting Body, Arsenic Trioxide, Gold, Mahonia 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, Sodium Chloride, Nitric Acid, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Sepia Officinalis Juice, Sulfur, Lycosa Tarantula, Thuja Occidentalis Leafy Twig, Zinc, Apis Mellifera, Hamamelis Virginiana Root Bark/stem Bark, Hexaplex Trunculus Hypobranchial Gland Juice
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Vaginitis - Feminine Care    Formulated for symptoms associated with vaginitis and leucorrhea such as itching, burning, dryness, swelling, snoreness and discharge.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Agaricus musc. 20x, Arsenicum alb. 20x, Aur. met. 20x, Berber. aqui. 20x, Caladium seguinum 20x, Candida albicans 20x, Cantharis 20x, Conium 20x, Graphites 20x, Helonias dioica 20x, Hydrastis 20x, Kali carb. 20x, Kreosotum 20x, Lycopodium 20x, Merc. viv. 20x, Murex purpurea 20x, Nat. mur. 20x, Nitricum ac. 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sepia 20x, Sulphur 20x, Tarentula hispana 20x, Thuja occ. 20x, Zinc. met. 20x, Apis mel. 8x, Hamamelis 8x, Hydrastis 8x, Apis mel. 3x, Hamamelis 3x, Hydrastis 3x.

PURPOSE SECTION

ABUSE SECTION

 Formulated for symptoms associated with vaginitis and leucorrhea such as itching, burning, dryness, swelling, snoreness and discharge.

INACTIVE INGREDIENT SECTION

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

QUESTIONS? SECTION

OTC - 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4486-12020-01-31C16284748780-19d75b9d0-49ab-f424-e053-dadaa90a57ceVaginitis - Feminine Care
55714-4486-22020-01-31C16284748780-19d75b9d0-49ab-f424-e053-dadaa90a57ceVaginitis - Feminine Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4486-1Vaginitis - Feminine Care29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4486-2Vaginitis - Feminine Care59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4486VAGINITIS - FEMININE 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.]3Legacy NDC, 2 package rows20140206_8c80c028-5cc1-313f-990d-c04c4452e10f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Amanita Muscaria Var. Muscaria Fruiting BodyACTIVE INGREDIENTDIF093I0373
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z3
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO3
Candida AlbicansACTIVE INGREDIENT4D7G21HDBC3
Chamaelirium Luteum RootACTIVE INGREDIENTDQV54Y5H3U3
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3713
Dieffenbachia SeguineACTIVE INGREDIENT01800C6E6B3
GoldACTIVE INGREDIENT79Y1949PYO3
GoldensealACTIVE INGREDIENTZW3Z11D0JV3
GraphiteACTIVE INGREDIENT4QQN74LH4O3
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS3
Hexaplex Trunculus Hypobranchial Gland JuiceACTIVE INGREDIENTIQV54TN60Y3
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4793
Lycosa TarantulaACTIVE INGREDIENT86M454L2TT3
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT3
Mahonia Aquifolium Root BarkACTIVE INGREDIENTVZJ9F3C3SB3
MercuryACTIVE INGREDIENTFXS1BY2PGL3
Nitric AcidACTIVE INGREDIENT411VRN1TV43
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA3
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV3
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C23
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X3
SulfurACTIVE INGREDIENT70FD1KFU703
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93973
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A3
Wood CreosoteACTIVE INGREDIENT3JYG22FD733
ZincACTIVE INGREDIENTJ41CSQ7QDS3
Amanita Muscaria Var. Muscaria Fruiting BodyACTIVE MOIETYDIF093I0373
Apis MelliferaACTIVE MOIETY7S82P3R43Z3
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV3
Candida AlbicansACTIVE MOIETY4D7G21HDBC3
Carbonate IonACTIVE MOIETY7UJQ5OPE7D3
Chamaelirium Luteum RootACTIVE MOIETYDQV54Y5H3U3
Chloride IonACTIVE MOIETYQ32ZN486983
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3713
Dieffenbachia SeguineACTIVE MOIETY01800C6E6B3
GoldACTIVE MOIETY79Y1949PYO3
GoldensealACTIVE MOIETYZW3Z11D0JV3
GraphiteACTIVE MOIETY4QQN74LH4O3
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS3
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4793
Lycosa TarantulaACTIVE MOIETY86M454L2TT3
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT3
Mahonia Aquifolium Root BarkACTIVE MOIETYVZJ9F3C3SB3
MercuryACTIVE MOIETYFXS1BY2PGL3
Nitric AcidACTIVE MOIETY411VRN1TV43
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV3
Sea Snail, UnspecifiedACTIVE MOIETYCB4V7Q47ZT3
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C23
SulfurACTIVE MOIETY70FD1KFU703
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93973
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A3
Wood CreosoteACTIVE MOIETY3JYG22FD733
ZincACTIVE MOIETYJ41CSQ7QDS3
AlcoholINACTIVE INGREDIENT3K9958V90M3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-448655714-4486-1, 55714-4486-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
646483d3-fb37-59bd-c0f8-abdb22388ad28c80c028-5cc1-313f-990d-c04c4452e10f2011-06-01WarningsExact identifier
spl id: 646483d3-fb37-59bd-c0f8-abdb22388ad2
spl set id: 8c80c028-5cc1-313f-990d-c04c4452e10f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.