FDA Label for Terramed Just Think Comfort Yeast Relief

View Indications, Usage & Precautions

Terramed Just Think Comfort Yeast Relief Product Label

The following document was submitted to the FDA by the labeler of this product Rida 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



Olive Extract (oleuropein)                      3X HPUS
Hydrastis Canadensis                            5X HPUS
Borax (Sodium Borate)                          3X HPUS
Calendula Officinalis                              1X HPUS


Purpose



Anti-microbial and Healing agent


Uses



This product is intended to relieve symptoms associated with known yeast infections, including fishy odor, excess discharge, irritation and burning while urinating.


Warnings



  • For vaginal use only.
  • Do not use if you have never had vaginal infection diagnosed by a doctor.
  • Ointment may damage condoms and diaphragms and cause them to fail.
  • 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.
    • bacterial vaginosis 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 the human immunodeficiency virus (HIV) that causes AIDS.
    • Do not use if you are allergic to any ingredient in this product
    • 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 infections (STIs)
      • do not have vaginal intercourse
      • mild increase in vaginal burning, itching, or irritation may occur
      • if you do not get relief, consult a doctor
      • Stop use and ask a doctor if
        • symptoms do not get better in 3 days
        • symptoms last more than 7 days
        • you get a rash or hives, abdominal pain, fever, chills, nausea or vomiting

        • If pregnant or breast-feeding ask a healthcare professional before use.
        • Keep out of the reach of children If swallowed, get medical help or contact Poison Control Center right away

Directions



For individuals aged 12 and older:

  • Utilize this product before bedtime; refer to the enclosed instructions for comprehensive guidance. 
  • Place a panty liner in your underwear to prevent any potential leakage. 
  • While lying in bed, gently insert the applicator into the vagina and administer the ointment. Stay in a reclined position to minimize the risk of leakage. 
  • Dispose of the applicator after a single use.
  • Children under 12 years: Ask a doctor


Inactive Ingredients



Chitosan, povidone-iodine, Sodium hyaluonate, Chammomile Extract, Radix Curcumae extract, Rhizoma Sparganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated olive oil


Other Information



• Avoid usage if the applicator wrapper is damaged, opened, or not fully sealed.
• Do not use if the seal over the tube opening has been pierced.
• Store between 68°-77°F (20°C - 25°C). If the product liquefies, refrigerate it for 10 minutes to regain its thickness

Please note that this treatment consists of 7 doses. While many women may not experience complete symptom relief within just two days, most will notice some improvement in that timeframe and should expect complete relief within seven days.


Product Label




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