JILGYUNGYI (20 TABLETS)- allantoin tablet
Haudongchun Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Jilgyungyi (20 Tablets)

Allantoin (11%)

Vaginal skin protectant

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away. (1-800-222-1222)

Uses
 Moisturizes vaginal dryness
 Relieves external itching

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 36°C), pain in abdomen, odor, lumbar pain, abnormal secretion, nausea and abnormal shoulder pain.

Dosage and Duration Information
 For adults – 2 tablets at the same time
 Keep use 2 days consecutively and prefer to use once 10 days in 2 months. (after then, use it when you need)
 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) Do not remove moisture, 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 loaded applicator into the vagina as far as it will comfortably go.
3) It is preferable 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.

Sodium Chloride, Soluble Collagen, Glucose, Magnesium Stearate, Aloe Barbadensis Leaf Extract, Cereus Grandiflorus (Cactus) Extract, Ginkgo Biloba Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Centella Asiatica Extract, Sophora Flavescens Root Extract, Angelica Gigas Root Extract

Jilgyungyi (20 Tablets)

Jilgyungyi 20 tablets

JILGYUNGYI (20 TABLETS)
allantoin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55618-2004
Route of Administration	VAGINAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.11 in 600 mg

Ingredient Name	Strength
Inactive Ingredients
Sodium Chloride (UNII: 451W47IQ8X)
.ALPHA.-D-GLUCOPYRANOSE (UNII: 5J5I9EB41E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GINKGO (UNII: 19FUJ2C58T)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	14mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55618-2004-3	2 in 1 PACKAGE	07/07/2016
1	NDC:55618-2004-2	10 in 1 BLISTER PACK
1	NDC:55618-2004-1	600 mg in 1 CAPSULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/07/2016

Labeler - Haudongchun Co., Ltd. (688479464)

Registrant - Haudongchun Co., Ltd. (688479464)

Name	Address	ID/FEI	Business Operations
Establishment
Haudongchun Co., Ltd.		688479464	manufacture(55618-2004)

Revised: 7/2016

Document Id: 8af4a8d4-7142-4e80-ac01-3e3ffe5ecda8

Set id: 9b0c569d-9159-4170-8ea8-fd21ef5a28e5

Version: 2

Effective Time: 20160711

Haudongchun Co., Ltd.