Label: TERRAMED JUST THINK COMFORT GYNO CARE- olive extract,hydrastis,borax,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

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

  • Purpose

    Anti-microbial and Healing agent

  • 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.

  • Warnings

    • 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

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    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

    • 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

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

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRAMED JUST THINK COMFORT GYNO CARE 
    olive extract,hydrastis,borax,calendula officinalis gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83004-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN3 [hp_X]  in 100 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 100 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE3 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIGLUSAM (UNII: 82LKS4QV2Y)  
    POVIDONE-IODINE (UNII: 85H0HZU99M)  
    SODIUM (UNII: 9NEZ333N27)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CURCUMA KWANGSIENSIS ROOT (UNII: 2WSI2681TI)  
    SPARGANIUM STOLONIFERUM ROOT (UNII: 66ZQ85S65H)  
    CURCUMA ZEDOARIA WHOLE (UNII: J9130AL5GC)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83004-005-017 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)