MIRACLE GYN (2 TABLETS)- allantoin tablet

Miracle GYN (2 Tablets) by

Drug Labeling and Warnings

Miracle GYN (2 Tablets) by is a Otc medication manufactured, distributed, or labeled by Haudongchun Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Allantoin (11%)

Purpose

Vaginal skin protectant

Keep out of reach of children

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

Uses

 Relieves the following symptoms: vaginal irritation, itching and burning, odor, vaginal dryness

Warnings

 For vaginal use only
 Do not use if you have/are pregnant, hypersensitivity to any of the ingredients, scars on vagina, an allergic reaction or pain.

When using this product
 Do not use during menstruation.
 Use clean underwear.
 Do not use tampons, douches, condoms, feminine cleansers, or other vaginal products.
 Do not eat or swallow.

Stop use and ask a doctor if
 Symptoms get worsen or do not get better.
 Symptoms last more than 7 days
 You get rashes or hives, abdominal pain, fever, chills, nausea, vomiting or foul-smelling vaginal odor or discharge.

If pregnant or breast-feeding, ask a health professional before use.

Directions & Dosage

 Use it at bedtime preferably or during daytime without dynamic activites.
 Wash your finger and insert 2 pills into the vagina with first two knuckles of a finger. It will take 20-30 minutes until the pills are dissolved to relieve the symptoms and clean the vagina.
 Do not use within 6 hours prior to vaginal intercourse.

 This product is for adults and children age of 4 and up.
 Use 2 tablets at a time 2-4 consecutive days until symptoms are relieved.
 After then, keep using 2 tablets every week

Other Information
 Store at cool temperature and dry place

Inactive Ingredients

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

Miracle GYN (2 tablets)

INGREDIENTS AND APPEARANCE

MIRACLE GYN (2 TABLETS) 
allantoin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55618-2002
Route of Administration	VAGINAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55618-2002-3	1 in 1 PACKAGE	07/06/2016
1	NDC: 55618-2002-2	2 in 1 BLISTER PACK
1	NDC: 55618-2002-1	600 mg in 1 CAPSULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/06/2016

Labeler - Haudongchun Co., Ltd. (688479464)

Registrant - Haudongchun Co., Ltd. (688479464)

Establishment
Name	Address	ID/FEI	Business Operations
Haudongchun Co., Ltd.		688479464	manufacture(55618-2002)