Label: TERRAMED JUST THINK COMFORT HYDRO- olive extract,calendula officinalis gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 26, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient      Purpose

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

    Calendula Officinalis         3X HPUS                 Anti-microbial and Healing agent

  • PURPOSE

  • 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 
  • KEEP OUT OF REACH OF CHILDREN

  • 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

  • INGREDIENTS AND APPEARANCE
    TERRAMED JUST THINK COMFORT HYDRO 
    olive extract,calendula officinalis gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83004-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN3 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POVIDONE-IODINE (UNII: 85H0HZU99M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HOPS (UNII: 01G73H6H83)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)  
    TARAXACUM MONGOLICUM WHOLE (UNII: 4E8QL88U6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83004-006-0110 in 1 BOX11/11/2023
    1100 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/11/2023
    Labeler - Rida LLC (004425803)