Label: MIRACLE GYN- allantoin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 27, 2015

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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

    • 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

    MIRACLE GYN

  • INGREDIENTS AND APPEARANCE
    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)
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