Terramed Just Think Comfort Gynocare Probiotics For Vaginal Use Ointment
FDA Label NDC 83004-023

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 Probiotics For Vaginal Use (NDC 83004-023). 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                               3X HPUS (Sodium Borate) 
Calendula Officinalis          1X HPUS,
Lactobacillus fermentum    0.0025%.

Purpose

Anti-microbal and healing agent

Uses

This product is intended to relieve symptoms associated with known bacterial vaginosis infections, including fishy odor, excess discharge, irritation and burning while urinating.

Warnings

For vaginal use only.

  • Do not use if you have never had a bacterial vaginosis infection diagnosed by a doctor.
  • Oinment may damage condoms and diaphragms and cause them to fail

    • When using this product

    • can be used in combination with other medications, please consult a healthcare professional 
    • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted infections
    • do not have vaginal intercourse
    • mild increase in vaginal burning, itching, or irritation may occur
    • if you do not get relief, consult a doctor

      • Stop use and ask a doctor if :

      • symptoms do not get better in 3 days
      • symptoms last more than 7 days
      • you get a rash or hives, addominal pain, fever, chills, nausea or vomtting
      • if pregnant or breast-feeding 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 and children 12 years or over:

Use at bed time, read enclosed instructions for complete directions.

to protect cloths, use panty liner

lie down in bed. Insert applicator into vagina and inject ointment. Remain lying down to avoid leakage

discard applicator after use. DO NOT reuse.

children under 12 years : ask a doctor 

Other Information

  • do not use if applicator wrappear is torn, open or incompletely sealed
  • do not use if seal over tube opening has been punctured
  • store at 68° - 77° F (20° to 25° C) if liquefied, refrigerate 10minutes to thicken.

Inactive Ingredients

Chitosan, Collagen peptide, Sodium hyaluronate, Chamomile extract, Radix curcumae extract. Rhizome spaganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated Olive Oil, Amino acid.

Product Label

Image Description (Image 23)

Image Description (Image 23)

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