MIRACLE GYN- allantoin tablet

MIRACLE GYN by

Drug Labeling and Warnings

MIRACLE GYN by is a Otc medication manufactured, distributed, or labeled by HA U DONG CHUN. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Do not use during pregnant, breast-feeding, or menstrual cycle.
• Keep this product out of reach of children under 3 years old.

DOSAGE & ADMINISTRATION

For vaginal use only.

OTHER SAFETY INFORMATION

• Keep product out of direct sunlight, high temperature and humidity.
• Store in a cool dry place.
• Any items past the expiration date, spoiled, or damaged in transit can be exchanged where you originally purchased the item.

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

INGREDIENTS AND APPEARANCE

MIRACLE GYN 
allantoin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55618-2001
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.2

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	score with uneven pieces
Shape	OVAL	Size	12mm
Flavor		Imprint Code	3;hp;x
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55618-2001-1	1 in 1 PACKAGE
1		20 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/26/2015

Labeler - HA U DONG CHUN (688479464)

Registrant - HA U DONG CHUN (688479464)

Establishment
Name	Address	ID/FEI	Business Operations
HA U DONG CHUN		688479464	manufacture(55618-2001)