The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Terramed Just Think Comfort Gynocare Bv Guard Vaginal Symptoms Relief (NDC 83004-046). 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 ingredients (per applicator) ..................purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Borax 3X HPUS (Sodium Borate) Homeopathic*
Calendula officinalis 1X HPUS Homeopathic*
Hydrastis canadensis 5X HPUS Homeopathic*
Olive Extract (Oleuropein) 3X HPUS Homeopathic*
*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
For the temporary relief of minor vaginal discomfort and feelings of irritation.
For vaginal use only. Do not swallow.
For adult use only.
Do not use
• if you have never had vaginal symptoms before
• if you are allergic to any of the ingredients in this product
• if you have fever, chills, abdominal pain, or pelvic pain
• if you have abnormal vaginal bleeding
• if the applicator wrapper or seal is damaged, torn, or shows incomplete seals
When using this product
• you may experience mild burning, itching, or irritation at the application site
• do not use tampons, douches, spermicides, or other vaginal products
• this product may damage condoms and diaphragms and reduce their effectiveness
• avoid contact with eyes
Ask a doctor before use if you have
• diabetes, a weakened immune system, or a history of recurrent vaginal infections
• a serious medical condition or are under medical supervision
• symptoms that have lasted more than 7 days before starting use
Stop use and ask a doctor if
• symptoms do not improve within 3 days
• symptoms last more than 7 days
• symptoms worsen or return after completion
• new symptoms develop, including fever, rash, pelvic pain, nausea, or unusual bleeding
• severe burning, swelling, or rash occurs at the application site
If pregnant or breastfeeding, ask a healthcare professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
• adults: insert one (1) applicator vaginally at bedtime
• use once daily for up to 7 consecutive nights
• do not use more than one applicator in any 24-hour period
• children under 12 years: ask a doctor
• do not use if foil pouch or seal is damaged or previously opened
• store at 20–25 °C (68–77 °F); excursions permitted to 15–30 °C (59–86 °F)
• protect from direct heat and sunlight
• do not refrigerate unless product softens or loses shape
Chamomilla Recutita (Chamomile) Extract, Chitosan, Collagen Peptide, Curcuma Zedoaria Extract, Oxygenated Olive Oil, Radix Curcumae Extract, Rhizoma Sparganii Extract, Sodium Hyaluronate, Sophora Flavescens (Kuh-seng) Extract.
*Claims based on traditional homeopathic practice and not on modern scientific evidence.
Image Description (Image 46)
* Please review the disclaimer below.
