Terramed Just Think Comfort Homeopathic Vaginal Treatment For Yeast Infection Symptoms Relief Suppository
FDA Label NDC 83004-043

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 Homeopathic Vaginal Treatment For Yeast Infection Symptoms Relief (NDC 83004-043). 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.

Label Section Quick Index

Active Ingredient

Pulsatilla pratensis 5X HPUS, Borax 5X HPUS, Calendula officinalis 5X HPUS, Olea europaea 5X HPUS.

Purpose

For symptoms of intimate irritation; for symptoms of burning and discomfort; for symptoms of intimate discomfort.

Uses

For the temporary relief of symptoms associated with: minor intimate irritation; minor burning, itching, and discomfort; intimate odor.

Warnings

For vaginal use only. For adult use only.

Do not use:

  • if you are pregnant or breastfeeding, unless directed by a doctor
  • if you have pelvic pain, fever, chills, or abnormal vaginal bleeding
  • if you have unusual discharge with a foul odor
  • if you have never had vaginal symptoms before
  • if you are allergic to any ingredient in this product
  • if the foil packet is damaged, torn, or previously opened

    • Ask a doctor before use if you have:

    • diabetes, a weakened immune system, or 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 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, 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 18 years: do not use.

Inactive Ingredients

Aloe Vera Leaf Extract, Coconut (Cocos Nucifera) Oil, Saffron (Crocus Sativus) Extract, Yellow Cedar (Thuja Occidentalis) Extract, Tocopherol (Vitamin E), Purified Water.

Other Information

  • Store at 20°C–25 °C (68°F–77 °F)
  • excursions permitted to 15–30 °C (59–86 °F). 
  • Protect from direct heat and sunlight. 
  • Do not use if foil seal is broken, damaged, or previously opened.

Product Label

Image Description (Updated Image V3)

Image Description (Updated Image V3)

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