Label: TERRAMED JUST THINK COMFORT YEAST RELIEF- 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 intended to relieve symptoms associated with known yeast infections, including fishy odor, excess discharge, irritation and burning while urinating.

  • Warnings

    • For vaginal use only.
    • Do not use if you have never had vaginal infection diagnosed by a doctor.
    • Ointment may damage condoms and diaphragms and cause them to fail.

    Ask a doctor before use if you have:

    • vaginal itching and discomfort for the first time
    • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition.
    • bacterial vaginosis often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
    • been exposed to the human immunodeficiency virus (HIV) that causes AIDS.
    • Do not use if you are allergic to any ingredient in this product

    When using this product

    • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted infections (STIs)
    • do not have vaginal intercourse
    • mild increase in vaginal burning, itching, or irritation may occur
    • if you do not get relief, consult a doctor

    Stop use and ask a doctor if
    • symptoms do not get better in 3 days
    • symptoms last more than 7 days
    • you get a rash or hives, abdominal pain, fever, chills, nausea or vomiting

    • If pregnant or breast-feeding ask a healthcare professional before use.
    • Keep out of the reach of children If swallowed, get medical help or contact Poison Control Center right away
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    For individuals aged 12 and older:

    • Utilize this product before bedtime; refer to the enclosed instructions for comprehensive guidance. 
    • Place a panty liner in your underwear to prevent any potential leakage. 
    • While lying in bed, gently insert the applicator into the vagina and administer the ointment. Stay in a reclined position to minimize the risk of leakage. 
    • Dispose of the applicator after a single use.

    Children under 12 years: Ask a doctor

  • Inactive Ingredients

    Chitosan, povidone-iodine, Sodium hyaluonate, Chammomile Extract, Radix Curcumae extract, Rhizoma Sparganil extract, Curcuma zedoary extract, Kuh-seng extract, Oxygenated olive oil

  • Other information

    • Avoid usage if the applicator wrapper is damaged, opened, or not fully sealed.
    • Do not use if the seal over the tube opening has been pierced.
    • Store between 68°-77°F (20°C - 25°C). If the product liquefies, refrigerate it for 10 minutes to regain its thickness

    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 YEAST RELIEF 
    olive extract,hydrastis,borax,calendula officinalis gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83004-004
    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:83004-004-017 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)