TERRASIL RAPID-RELIEF VAGINAL (MICONAZOLE NITRATE, THUJA OCCIDENTALIS) KIT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

TERRASIL RAPID-RELIEF VAGINAL (MICONAZOLE NITRATE, THUJA OCCIDENTALIS) KIT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-189-25, 24909-190-25
Set ID 6779a496-bfb1-4bee-9eae-a49416d080f5
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active Ingredient

    Ointment: Miconazole Nitrate 2%
    Cleansing Bar: Thuja Occidentalis 6X HPUS

  • Purpose

    Vaginal Antifungal

  • Uses

    Treats vaginal yeast infections.

  • KEEP OUT OF REACH OF CHILDREN

  • Warnings

    For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. Ask a doctor before use if you have
    ● vaginal itching and discomfort for the first time
    ● lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling
    vaginal discharge. You may have a more serious condition.
    ● vaginal yeast infections often (such as once a month or 3 in 6 months).
    You could be pregnant or have a serious underlying medical cause for your
    symptoms, including diabetes or a weakened immune system.
    ● been exposed to human immunedeficiency virus (HIV) that causes AIDS. Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine
    warfarin, because bleeding or bruising may occur. When using this product
    ● do not use tampons, douches, spermicides, or other vaginal products.
    Condoms and diaphragms may be damaged and fail to prevent pregnancy
    or sexually transmitted disease (STDs).
    ● do not have vaginal intercourse
    ● mild increase in vaginal burning, itching, or irritation may occur
    ● if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if
    ● symptoms do not get better after 3 days
    ● symptoms last more than 7 days
    ● you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. If pregnant or breast feeding, ask a health professional before use.

  • Directions

    Children under 12: Ask a doctor.
    Adults and children 12 years and over:
    Ointment: May be used topically (outside the vaginal area) or intravaginally.
    Squeeze a small amount of ointment onto fingertip.
    Apply 2-3 times daily for up to 3 days or longer, as needed. May stain fabrics.
    Cleansing Bar: Wash affected areadaily. Store at room temperature.

  • Inactive Ingredients

    Ointment: beeswax (organic), bentonite (volcanic clay), cottonseed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, stearic acid, tea tree oil, zinc oxide.

    Cleansing Bar: beeswax, bentonite clay, coconut oil, cottonseed oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, stearic acid, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

  • PRINCIPAL DISPLAY PANEL - BOX

    Vaginal Discomfort

    • Vaginal Itch
    • Odor and Discharge
    • Yeast Infection and Vaginitis

    All Natural

    terrasil

    RAPID-RELIEF VAGINAL OINTMENT

    Plus Medicated Cleansing Bar

    2X FASTER

    compared to leading brands
    in scientific studies

    THE END OF SUFFERING

    Healing and Relief Since 2004

    Box

  • INGREDIENTS AND APPEARANCE
    TERRASIL RAPID-RELIEF VAGINAL 
    miconazole nitrate, thuja occidentalis kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-190
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-190-251 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package01/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 25 g
    Part 21 CARTON 75 g
    Part 1 of 2
    TERRASIL RAPID-RELIEF VAGINAL 
    miconazole nitrate ointment
    Product Information
    Item Code (Source)NDC:24909-189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-189-2525 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/18/2014
    Part 2 of 2
    TERRASIL VAGINAL CLEANSING BAR 
    thuja occidentalis soap
    Product Information
    Item Code (Source)NDC:24909-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (MICONAZOLE - UNII:7NNO0D7S5M) THUJA OCCIDENTALIS WHOLE6 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    COTTONSEED OIL (UNII: H3E878020N)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PALM ACID (UNII: B6G0Y5Z616)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SORBITOL (UNII: 506T60A25R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    175 g in 1 CARTON; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-190) , label(24909-190)

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