MIRACLE GYN (10 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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Miracle GYN (10 tablets)

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 (10 tablets)

miraclegyn 10tablets

MIRACLE GYN (10 TABLETS) 
allantoin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55618-2003
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.11   in 600 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapecapsuleSize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55618-2003-35 in 1 PACKAGE07/07/2016
1NDC:55618-2003-22 in 1 BLISTER PACK
1NDC:55618-2003-1600 mg in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/07/2016
Labeler - Haudongchun Co., Ltd. (688479464)
Registrant - Haudongchun Co., Ltd. (688479464)
Establishment
NameAddressID/FEIBusiness Operations
Haudongchun Co., Ltd.688479464manufacture(55618-2003)

Revised: 3/2017
Document Id: e65f9b4d-9935-48bd-bd97-f605cf9da06e
Set id: 7c9d3d94-62c5-4d2a-86c6-db72f30bdfd2
Version: 3
Effective Time: 20170324
 
Haudongchun Co., Ltd.