Terramed Just Think Comfort Hydro

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 Hydro
Active ingredientOLEUROPEIN, CALENDULA OFFICINALIS FLOWERING TOP
Label structure7 sections

Indications and uses

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

Dosage and administration

For individuals aged 12 and older: Remove the applicator from the sealed wrapper by tearing the easy-open notch. DO NOT open the applicator at this time. Grip the applicator firmly by the thick end. Shake down to ensure that the contents are at the thin end of the applicator. Bend the thin pointed end of the applicator back and forth repeatedly. Snap off the thin pointed end of the applicator and discard the tip. ...

Label contents#

Full prescribing information#

Active Ingredient      Purpose

OTC - ACTIVE INGREDIENT SECTION

Olive Extract (oleuropein) 3X HPUS                 Moisturing and Healing Agent

Calendula Officinalis         3X HPUS                 Anti-microbial and Healing agent

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For vaginal use only.
  • If pregnant or breast-feeding ask a healthcare professional before use.
  • Keep out of the reach of childrenIf swallowed, get medical help or contact Poison Control Center right away.
  • For adults only. Do not use it on children.
  • If vaginal irritation occurs, stop using. If symptoms persist, contact your physician.
  • Store in dry and cool place at 2°-30°C 

Directions

DOSAGE & ADMINISTRATION SECTION

For individuals aged 12 and older:

  • Remove the applicator from the sealed wrapper by tearing the easy-open notch. DO NOT open the applicator at this time. Grip the applicator firmly by the thick end. Shake down to ensure that the contents are at the thin end of the applicator.
  • Bend the thin pointed end of the applicator back and forth repeatedly. Snap off the thin pointed end of the applicator and discard the tip.
  • DO NOT use scissors or tools to cut the applicator tip
  • Bend your knees while sitting, standing or lying on your back and gently insert the open end of the applicator right into the vagina.
  • Firmly press the thick end of the applicator to deposit the gel.
  • Remove the applicator and discard in waste container.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, povidone-iodine, Hyaluronic Acid, Tocopherol Acetate (vitamin E), Carbomer, Sodium Hydroxideb, Sodium Edetate, Hop Extract, Organic olive oil, Organic Avocado oil, Fructus Cnidii Extract, Taraxacum Mongolicum Extract

Other information

SPL UNCLASSIFIED SECTION

Please note that this treatment consists of 7 doses. While many women may not experience complete symptom relief within just two days, most will notice some improvement in that timeframe and should expect complete relief within seven days.

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
83004-006-012025-03-10C16284748780-12cef2736-abda-d83d-e063-dadaa90ab31fDrug Facts
83004-006-012025-01-30C16284748780-12cef2736-abda-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-006-01Terramed Just Think Comfort Hydro10 in 1 BOXGEL103
83004-006-01Terramed Just Think Comfort Hydro100 mL in 1 APPLICATORGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-006TERRAMED JUST THINK COMFORT HYDRO (OLIVE EXTRACT,CALENDULA OFFICINALIS) GEL [RIDA LLC]32 package rows20250312_43505966-6131-459a-9858-aaeb25cdd7dd.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83004-00683004-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
558dbca6-add6-fdb9-e063-6294a90a196a43505966-6131-459a-9858-aaeb25cdd7dd2026-07-01WarningsExact identifier
spl set id: 43505966-6131-459a-9858-aaeb25cdd7dd

Reported adverse events (FAERS/openFDA)#

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