Label: VAGI-SOOTHE - oyster shell calcium carbonate, crude, wood creosote, lycopodium clavatum spore, mercurius solubilis and sepia officinalis juice tincture

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

If you are a consumer or patient please visit this version.

  • PURPOSE

    Relieves vaginal itching, burning and soreness

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  • ACTIVE INGREDIENT

    Active Ingredients:Each dose contains equal parts of: Calc carb 6C HPUS, Kreosotum 12C HPUS, Lycopodium 12C HPUS, Merc sol 30C HPUS, Sepia 6C HPUS

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  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for the relief of vaginal itching, irritation, odor and discomfort

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  • WARNINGS

    Warning: If symptoms persist or worsen, consult a healthcare professional

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  • PREGNANCY OR BREAST FEEDING

    If pregnant of breastfeeding, ask a health professional before use

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children

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  • OVERDOSAGE

    In case of overdose, get medical help pr contact a Posion Control Center right away

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  • DOSAGE & ADMINISTRATION

    Directions: Adults: Mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat 3-5 times daily as needed until symptoms subside. If preferred, drops may be taken directly into the mouth

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  • INACTIVE INGREDIENT

    Inactive Ingredients: USP Purified water, grain alcohol (20% by volume)

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  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially  monographed in the Homeopathic Pharmacopoeia of the United States

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us a www.nativeremedies.com

    Distributed by
    Native Remedies, LLC
    6531 Park of Commerce Blvd.
    Suite 160
    Boca Raton, Fl 33487
    Phone: +1.877.289.1235
    International: +1.561.999.8857

    Contains no animal products, gluten, artificial flavors, preservatives or colorants. Suitable for vegetarians

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  • STORAGE AND HANDLING

    Tamper resistant for your protection. Use only if safety seal is intact

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  • INGREDIENTS AND APPEARANCE
    VAGI-SOOTHE 
    calc carb, kreosotum, lycopodium, merc sol, sepia tincture
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68703-097
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 6 [hp_C]  in 1 mL
    WOOD CREOSOTE (WOOD CREOSOTE) WOOD CREOSOTE 12 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 12 [hp_C]  in 1 mL
    MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 30 [hp_C]  in 1 mL
    SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 6 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68703-097-59 59 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved medical gas 03/29/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    Name Address ID/FEI Business Operations
    Vitality Works Inc 137752817 manufacture(68703-097), api manufacture(68703-097)
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