Label: MIRACLE GYN (2 TABLETS)- allantoin tablet

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

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.

Drug Label Information

Updated March 24, 2017

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  • 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)

    miraclegyn 2tablets

  • INGREDIENTS AND APPEARANCE
    MIRACLE GYN (2 TABLETS) 
    allantoin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55618-2002
    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:55618-2002-31 in 1 PACKAGE07/06/2016
    1NDC:55618-2002-22 in 1 BLISTER PACK
    1NDC:55618-2002-1600 mg in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/06/2016
    Labeler - Haudongchun Co., Ltd. (688479464)
    Registrant - Haudongchun Co., Ltd. (688479464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haudongchun Co., Ltd.688479464manufacture(55618-2002)