MIRACLE GYN- allantoin tablet 
HA U DONG CHUN

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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ACTIVE INGREDIENT

Allantoin

PURPOSE

Relives the following symptoms; yeast infection, vaginal itching and irritation, vaginal dryness and odor, menstrual cramps, urinary incontinence, vaginal tightness.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

This product is to be used in the vagina. Use it at bedtime, or during the day without dynamic activities. Insert the pills into your vagina with first two knuckles of your finger. During the 20 to 30 minutes the pills are melted and they are effective in improving vaginal health.

WARNINGS

DOSAGE & ADMINISTRATION

For vaginal use only.

OTHER SAFETY INFORMATION

INACTIVE INGREDIENT

Sodium chloride, collagen, glucose, magnesium stearate, aloe extract, opuntia ficus-indica extract, menthe aryensis extract, centella asiatica extract, sophora flavescens aiton extract, angelica acutiloba extract

PACKAGE LABEL

MIRACLE GYN

MIRACLE GYN 
allantoin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55618-2001
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.2 
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (UNII: 9X7O8V25IT)  
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ALOE (UNII: V5VD430YW9)  
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
ANGELICA ACUTILOBA ROOT OIL (UNII: 96L0Z12X98)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeOVALSize12mm
FlavorImprint Code 3;hp;x
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55618-2001-11 in 1 PACKAGE
120 in 1 BOTTLE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/26/2015
Labeler - HA U DONG CHUN (688479464)
Registrant - HA U DONG CHUN (688479464)
Establishment
NameAddressID/FEIBusiness Operations
HA U DONG CHUN688479464manufacture(55618-2001)

Revised: 6/2015
Document Id: 19856cd9-ba1c-06a4-e054-00144ff8d46c
Set id: 19856cd9-ba1b-06a4-e054-00144ff8d46c
Version: 1
Effective Time: 20150627
 
HA U DONG CHUN