Terramed Just Think Comfort Gyno Care Gel
FDA Label NDC 83004-005

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 Gyno Care (NDC 83004-005). 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

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 designed to alleviate symptoms linked to recognized bacterial vaginosis infecfions, such as a pungent odor, excessive discharge, as well as discomfort and a burning sensation during urination.

Warnings

  • For vaginal use only.
  • Do not use if you have never had bacterial vaginosis infection diagnosed by a doctor.
  • Ointment may damage condoms and diaphragms, potentially leading to their Ineffectiveness.

    • When using this product:

    • If considering its use in conjunction with other medications, it is advisable to seek guidance from a healthcare professional.
    • Avoid the use of tampons, douches, spermicides, or other vaginal products. This is to prevent potential damage to condoms and diaphragms, which could result in a failure to provide adequate protection against pregnancy or sexually transmitted infections (STIs).
    • Refrain from engaging in vaginal intercourse
    • Be aware that there may be a slight uptick in vaginal burning, itching, or irritation
    • If relief is not attained, it is recommended to consult a doctor.

      • Stop use and ask a doctor if

      • symptoms do not get better in 3 days
      • symptoms persist for more than 7 days
      • You experience a rash or hives, abdominal pain, fever, chills, nausea, or vomiting.

        • If pregnant or breast-feedingask a healthcare professional before use.

        Keep out of the reach of childrenIf swallowed, get medical help or contact Poison Control Center right away

Directions

Adults and children 12 years or over

Administer before bedtime, and consult the enclosed instructions for comprehensive guidance.

  • To safeguard clothing. employ a panty liner.
  • Recline on your bed. introduce the applicator into the vagina and dispense the ointment.Continue lying down to prevent any leakage.
  • After use, dispose of the applicator. DO NOT attempt to reuse it.
  • Children under 12 years: seek advice from a medical professional.

Other Information

  • Avoid usage if the applicator wrapper exhibits any tears, openings, or incomplete seals.
  • Do not use if the seal covering the tube opening has been punctured.
  • Keep it stored at a temperature range of 68°F - 77°F {20°C - 25°C]. In the event of liquefaction, refrigerate for 10 minutes to achieve a thicker consistency
  • This treatment consists of 7 doses. Typically, full symptom relief may not be achieved within just two days. Most women experience some improvement within two days. with complete relief typically occurring within seven days.

Inactive Ingredients

Chitosan, povidone-iodine, Sodum hyaluronate, Chamomile extract, Radix curcumae extract, Rhizome sparganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated Olive Oil

Product Label

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Image Description (Label)

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