Vaginitis - Feminine Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:08

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:  Ages 12 and up, take 6 pellets orally (ages 6 to 11, give 3 pellets) 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:  Gluten-free, non-GMO, beet-derived sucrose pellets.        

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
55714-4487-12020-01-31C16284748780-19d75b9d0-30cd-f424-e053-dadaa90a57ceVaginitis - Feminine Care
55714-4487-22020-01-31C16284748780-19d75b9d0-30cd-f424-e053-dadaa90a57ceVaginitis - Feminine Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4487-1Vaginitis - Feminine Care28.35 g in 1 BOTTLE, GLASSPELLET28.351
55714-4487-2Vaginitis - Feminine Care56.7 g in 1 BOTTLE, GLASSPELLET56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4487VAGINITIS - 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) PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20131105_2970ff61-3c7a-c55d-ee8e-628a7bdd2fa5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Amanita Muscaria Var. Muscaria Fruiting BodyACTIVE INGREDIENTDIF093I0371
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Candida AlbicansACTIVE INGREDIENT4D7G21HDBC1
Chamaelirium Luteum RootACTIVE INGREDIENTDQV54Y5H3U1
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3711
Dieffenbachia SeguineACTIVE INGREDIENT01800C6E6B1
GoldACTIVE INGREDIENT79Y1949PYO1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
GraphiteACTIVE INGREDIENT4QQN74LH4O1
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS1
Hexaplex Trunculus Hypobranchial Gland JuiceACTIVE INGREDIENTIQV54TN60Y1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Lycosa TarantulaACTIVE INGREDIENT86M454L2TT1
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT1
Mahonia Aquifolium Root BarkACTIVE INGREDIENTVZJ9F3C3SB1
MercuryACTIVE INGREDIENTFXS1BY2PGL1
Nitric AcidACTIVE INGREDIENT411VRN1TV41
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X1
SulfurACTIVE INGREDIENT70FD1KFU701
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93971
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Wood CreosoteACTIVE INGREDIENT3JYG22FD731
ZincACTIVE INGREDIENTJ41CSQ7QDS1
Amanita Muscaria Var. Muscaria Fruiting BodyACTIVE MOIETYDIF093I0371
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Candida AlbicansACTIVE MOIETY4D7G21HDBC1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Chamaelirium Luteum RootACTIVE MOIETYDQV54Y5H3U1
Chloride IonACTIVE MOIETYQ32ZN486981
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3711
Dieffenbachia SeguineACTIVE MOIETY01800C6E6B1
GoldACTIVE MOIETY79Y1949PYO1
GoldensealACTIVE MOIETYZW3Z11D0JV1
GraphiteACTIVE MOIETY4QQN74LH4O1
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Lycosa TarantulaACTIVE MOIETY86M454L2TT1
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT1
Mahonia Aquifolium Root BarkACTIVE MOIETYVZJ9F3C3SB1
MercuryACTIVE MOIETYFXS1BY2PGL1
Nitric AcidACTIVE MOIETY411VRN1TV41
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Sea Snail, UnspecifiedACTIVE MOIETYCB4V7Q47ZT1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
SulfurACTIVE MOIETY70FD1KFU701
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93971
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Wood CreosoteACTIVE MOIETY3JYG22FD731
ZincACTIVE MOIETYJ41CSQ7QDS1
SucroseINACTIVE INGREDIENTC151H8M5541

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
55714-448755714-4487-1, 55714-4487-2

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

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 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
2c67cb15-4a93-89a8-bf3e-86a0dc0a0a082970ff61-3c7a-c55d-ee8e-628a7bdd2fa52011-06-01WarningsExact identifier
spl id: 2c67cb15-4a93-89a8-bf3e-86a0dc0a0a08
spl set id: 2970ff61-3c7a-c55d-ee8e-628a7bdd2fa5

Reported adverse events (FAERS/openFDA)#

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