Terramed Just Think Comfort gyno care

Manufacturer
Rida LLC
Effective date
2025-03-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:32:25

Label at a glance#

ProductTerramed Just Think Comfort gyno care
Active ingredientOLEUROPEIN, GOLDENSEAL, SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP
Label structure8 sections

Indications and 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.

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Olive Extract (oleuropein)                      3X HPUS
Hydrastis Canadensis                            5X HPUS
Borax (Sodium Borate)                          3X HPUS
Calendula Officinalis                              1X HPUS

Purpose

OTC - PURPOSE SECTION

Anti-microbial and Healing agent

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83004-005-012025-03-10C16284748780-12cef2736-7aa2-d83d-e063-dadaa90ab31fDrug Facts
83004-005-012025-01-30C16284748780-12cef2736-7aa2-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-005-01Terramed Just Think Comfort gyno care100 mL in 1 APPLICATORGEL1003
83004-005-01Terramed Just Think Comfort gyno care7 in 1 BOXGEL73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-005TERRAMED JUST THINK COMFORT GYNO CARE (OLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALIS) GEL [RIDA LLC]32 package rows20250312_54b46411-0ff8-4b08-bf37-802b94acf5c1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83004-00583004-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
558daa86-df6f-e639-e063-6394a90a7cd954b46411-0ff8-4b08-bf37-802b94acf5c12026-07-01WarningsExact identifier
spl set id: 54b46411-0ff8-4b08-bf37-802b94acf5c1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.