Label: TERRAMED JUST THINK COMFORT GYNO CARE- olive extract,hydrastis,borax,calendula officinalis gel
- NDC Code(s): 83004-005-01
- Packager: Rida LLC
- 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
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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
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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.
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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
- Product label
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INGREDIENTS AND APPEARANCE
TERRAMED JUST THINK COMFORT GYNO CARE
olive extract,hydrastis,borax,calendula officinalis gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83004-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN 3 [hp_X] in 100 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 5 [hp_X] in 100 mL SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 3 [hp_X] in 100 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83004-005-01 7 in 1 BOX 11/11/2023 1 100 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/11/2023 Labeler - Rida LLC (004425803)