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  5. Label Information: Terramed Just Think Comfort Gyno Care

FDA Label for Terramed Just Think Comfort Gyno Care

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Terramed Just Think Comfort Gyno Care 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 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



image description - label

image description - label


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