Terramed Just Think Comfort Homeopathic Drug Hydrogyn Vaginal Moisturizer Gel
FDA Label NDC 83004-047

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 Drug Hydrogyn Vaginal Moisturizer (NDC 83004-047). 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 ingredients...........................................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.

Active Ingredients...........................................Purpose

Sepia officinalis 6X HPUS ..................................For symptoms of vaginal dryness
Calendula officinalis 3X HPUS ............................For symptoms of vaginal irritation

Uses

  • Temporarily relieves vaginal dryness. 
  • emporarily relieves discomfort due to vaginal dryness. 
  • Temporarily relieves discomfort during intimacy due to vaginal dryness. 
  • For the temporary relief of minor vaginal discomfort and feelings of irritation.

Warnings

For vaginal use only.

Do not use:

  • if you are allergic to any of the ingredients
  • if the foil pouch is damaged or previously opened
  • Ask a doctor before use if you have

    • a vaginal infection or are being treated for one
    • abnormal vaginal bleeding or discharge
    • any other vaginal or pelvic condition diagnosed by a healthcare professional
    • When using this product:

      • use only as directed;
      • do not use more than once every 48 hours unless directed by a healthcare professional;
      • mild burning, itching, or irritation may occur — if these worsen or persist, discontinue use;
      • avoid contact with eyes — if contact occurs, rinse thoroughly with water;
      • do not reuse or share applicators;
      • do not use with other intravaginal products (douches, spermicides, antifungal treatments) unless directed by a healthcare professional.
      • Stop use and ask a doctor if:

        • symptoms do not improve after 3 applications or worsen during use;
        • you experience severe vaginal irritation, abnormal discharge, or unexpected bleeding;
        • you develop fever, chills, or abdominal pain.
        • 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 

Directions

  • Adults: insert contents of one pre-filled applicator into the vagina up to once every 3 days, or as directed by a healthcare professional. 
  • Do not use more than once every 48 hours. 
  • Preferably at bedtime. 
  • (1) Wash hands. Open the foil pouch and remove the pre-filled applicator. Do not tamper with the applicator tip until ready to use. 
    (2) Recline on your back with knees bent, or stand or sit comfortably. 
    (3) Gently insert the thin end of the applicator into the vaginal opening until comfortable. 
    (4) Firmly press the thick end of the applicator to dispense the contents. 
    (5) Remove and discard the applicator after a single use. Do not reuse.

Other Information

  • Store between 20°C and 25°C (68°F to 77°F). 
  • Protect from excessive heat and direct sunlight. 
  • Single-use applicator only — discard after use.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract (Organic), Carbomer, Humulus Lupulus (Hop) Extract, Olea Europaea (Olive) Fruit Oil (Organic), Opuntia Ficus-indica (Prickly Pear) Extract, Persea Gratissima (Avocado) Oil (Organic), Purified Water, Sodium Edetate, Sodium Hyaluronate, Sodium Hydroxide, Taraxacum Mongolicum (Dandelion) Extract, Tocopheryl Acetate (Vitamin E).

Product Label

Image Description (Image 47)

Image Description (Image 47)

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