FDA Label for Terrasil Rapid-relief Vaginal

View Indications, Usage & Precautions

Terrasil Rapid-relief Vaginal Product Label

The following document was submitted to the FDA by the labeler of this product Aidance Skincare & Topical Solutions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



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


Purpose



Vaginal Antifungal


Uses



Treats vaginal yeast infections.


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


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