Terramed Just Think Comfort Yeast Relief Gel
FDA Label NDC 83004-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Terramed Just Think Comfort Yeast Relief (NDC 83004-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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