Label: VAGINITIS - 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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated June 1, 2011

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  • 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

    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

    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

     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

    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

    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

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    VAGINITIS - 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
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4486
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amanita Muscaria Var. Muscaria Fruiting Body (UNII: DIF093I037) (Amanita Muscaria Var. Muscaria Fruiting Body - UNII:DIF093I037) Amanita Muscaria Var. 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
    Mahonia Aquifolium Root Bark (UNII: VZJ9F3C3SB) (Mahonia Aquifolium Root Bark - UNII:VZJ9F3C3SB) Mahonia 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
    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
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf20 [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 Mellifera8 [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 Bark8 [hp_X]  in 1 mL
    Hexaplex Trunculus Hypobranchial Gland Juice (UNII: IQV54TN60Y) (Sea Snail, Unspecified - UNII:CB4V7Q47ZT) Hexaplex Trunculus Hypobranchial Gland Juice20 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4486-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-4486-259.14 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-4486)
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