Terramed Just Think Comfort Gynocare For Bacterial Vaginosis Symptoms Relief Suppository
FDA Label NDC 83004-041

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 Gynocare For Bacterial Vaginosis Symptoms Relief (NDC 83004-041). 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, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Borax 3X HPUS (Sodium Borate), Calendula officinalis 1X HPUS, Hydrastis canadensis 5X HPUS, Olive Extract (Oleuropein) 3X HPUS.       

Purpose

Homeopathic

Uses

For the temporary relief of minor vaginal discomfort and feelings of irritation.

Warnings

For vaginal use only. Do not swallow. For adult use only.

Do not use:

  • if you have never had vaginal symptoms before
  • if you are allergic to any of the ingredients in this product
  • if you have fever, chills, abdominal pain, or pelvic pain
  • if you have abnormal vaginal bleeding
  • if the foil packet is damaged, torn, or previously opened.

    • Ask a doctor before use if you have:

    • diabetes, a weakened immune system, or a history of recurrent vaginal infections
    • a serious medical condition or are under medical supervision;
    • symptoms that have lasted more than 7 days before starting use.

      • When using this product:

      • you may experience mild burning, itching, or irritation at the application site.
      • do not use tampons, douches, spermicides, or other vaginal products;
      • this product may damage condoms and diaphragms and reduce their effectiveness.
      • avoid contact with eyes.

        • Stop use and ask a doctor if:

        • symptoms do not improve within 3 days
        • symptoms last more than 7 days
        • symptoms worsen or return after completion.
        • new symptoms develop, including fever, rash, pelvic pain, nausea, or unusual bleeding
        • severe burning, swelling, or rash occurs at the application site.

          • If pregnant or breastfeeding, ask a healthcare professional before use.

          Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults: insert one (1) suppository vaginally at bedtime. Use once daily for up to 7 consecutive nights. Do not use more than one suppository in any 24-hour period. Children under 12 years: ask a doctor.

Other Information

Do not use if foil packet is damaged, torn, or previously opened. Store at 20–25 °C (68–77 °F); excursions permitted to 15–30 °C (59–86 °F). Protect from direct heat and sunlight. Do not refrigerate unless product softens or loses shape.

Inactive Ingredients

Aloe Vera Extract, Cnidium Monnieri (Snake Seed) Extract, Coconut Oil, Crocus Sativus (Saffron) Extract, Sophora Flavescens Extract, Thuja Occidentalis (Yellow Cedar) Extract, Tinospora Cordifolia (Golden Vine) Extract, Tocopherol (Vitamin E).

Product Label

Image Description (Updated Image 41)

Image Description (Updated Image 41)

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