Terramed Just Think Comfort Hydro Gel
FDA Label NDC 83004-006

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 Hydro (NDC 83004-006). 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, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient      Purpose

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

Calendula Officinalis         3X HPUS                 Anti-microbial and Healing agent

Uses

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

Warnings

  • 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

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

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

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

Image Description (Image 006)

Image Description (Image 006)

* Please review the disclaimer below.