Jilgyungyi
FDA Label NDC 73004-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jilgyungyi Co.,ltd. for the product Jilgyungyi (NDC 73004-010). 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 ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel - jilgyungyi 6 tablets, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active Ingredient: Glucose 50.97%, Sodium Chloride 35.50%

Inactive Ingredient

Inactive Ingredients:

Butylene glycol, Water, Allantoin, Opuntia ficus-indica extract, Centella asiatica extract, Aloe barbadensis leaf extract, Gingko biloba leaf extract, Mentha piperita(peppermint) leaf extract, Sophora angustifolia root extract, Angelica gigas root extract, 1,2-Hexanediol, Citric acid, Magnesium stearate, Soluble collagen, Sodium citrate

Purpose

Purpose: Odor care, Prevent vaginitis

Warnings

Warnings:

For vaginal use only
Do not use if you have (are)
- an allergic reaction (rashes, and pimples, redness, swelling, skin irritation, discomfort, burning, vaginal peeling or bleeding, pain in the abdomen or pelvic area, fluttering heartbeat and chest pain, lumbar pain, abnormal vaginal secretion, pollakisuria, abnormal dryness, excessive menstrual bleeding, odor and green colored vaginal secretion, hypotension, faint, and papulopustule, pelvic pain)
- pregnant
- hyper sensitive skin and skin ailment
- scars on vagina
- itching, rash, swelling, redness, discomfort, burning, irritation vaginal peeling or bleeding
When using this product
- do not use while having the monthly menstrual period
- prior to absorption there is a risk the tablet may fall out of the vagina
- often wash towels or underwear and do not wear reuse underwear again prior to washing due to risk of infections
- try to avoid sexual relations when you have vaginal yeast infection, it can be aggravated
- try not to use tampons and feminine cleansers
- avoid contact with eye area
- do not eat or swallow
- do not use rubber products such as latex, condoms, and diaphragms together
- do not use other vaginal tablets while using Jil Gyung Yi
If pregnant or breast-feeding, do not use.

Store at cool temperature and dry place with a closed container. Avoid direct sunlight

Overdose warning
- If you accidentally take the tablet orally, stop using this medication and see doctor immediately.

Stop use and ask a doctor if you have
- fever (over 38°C), pain in abdomen, odor, lumbar pain, abnormal secretion, nausea and abnormal shoulder pain.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Indications & Usage

Uses:

Moisturizes vaginal dryness and helps to improve elasticity
Relieves external itching and alleviates odors before and after the menstruation

Dosage & Administration

Directions:

For adults – 2 tablets at the same time
- For a first-timer, keep use 2 days consecutively and after that, use once a week.
- Do not use up to 6 hours prior to any sexual relation.
- Do not use up to 6 months after giving birth.
- Symptoms may vary depending on the age of the patient.

Directions
- Use only adults and children 12 years age and over
1) Wash hands before using this product
2) Open the package and vaginal tablets are placed into the vagina in much the same way as a tampon stand, squat, or lie on your back in a comfortable position then insert the tablets into the vagina as far as it will comfortably go.
3) It is recommended to use the treatment during night time prior to bed.
4) Use of a sanitary pad after application, because there may be vaginal secretion 30min after application. If there are lots of secretion, change a new sanitary pad.
5) Wash the area around the vagina (the vulva) gently next day, bacteria in your vaginal secretion can cause itching.

* Please review the disclaimer below.