MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]

MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]
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NDC 69316-321-10
Set ID 7f4a11c3-95bf-419b-8460-ea9d946fc724
Category HUMAN OTC DRUG LABEL
Packager Damiva Inc.
Generic Name
Product Class
Product Number
Application Number
  • DRUG FACTS

    Active ingredients

    Calendula HPUS 1X and 

    Hamamelis HPUS 6X:

    each less than 1% w/w

  • PURPOSE

    Purpose

    Vaginal Discomfort

  • INDICATIONS & USAGE

    Uses:  For soothing relief of vaginal discomfort, dryness, itching, odor and pain.  These uses are based solely on usage in homeopathic medicine.  This product has not been evaluated by the Food and Drug Administration for safety or efficacy. 

  • Warnings

    For vaginal use only. 

    Do not use if you have an underlying gynecological medical condition or infection e.g. yeast or bacterial infection, sexually transmitted diseases, pelvic inflammatory disease, tenderness, swelling, discharge, chills, nausea, vomiting, rash or increased pain. 

    If symptoms persist or worsen, or if new symptoms appear, consult a doctor as these could be signs of a serious condition. 

    If you are pregnant or breast-feeding, ask a health professional before use. 

    Keep out of reach of children.  

    Store at 68-77 °F. 

  • DOSAGE & ADMINISTRATION

    Directions: Remove plastic wrap from ovule.  Using a clean finger, insert one suppository vaginally as far as comfortable.  Use as needed, or every 2 to 3 days, to a maximum of one ovule per day.  May use at bedtime to prevent product leakage.  Best results may occur after consecutive use of 10 ovules. 

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Garcinia indica, Invert Sugar, Sucrose, Theobroma cacao (<30% w/w)

  • PRINCIPAL DISPLAY PANEL

    100% natural
    vaginal suppository.


    Feel like a teenager again,
    but with better judgement.

    mae
    by damiva

    Homeopathic formula
    10 ovule suppositories 1.9 g each. Net weight 19 g.

    mae by damiva carton

  • INGREDIENTS AND APPEARANCE
    MAE BY DAMIVA 
    calendula and hamamelis suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69316-321
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    SUCROSE (UNII: C151H8M554)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Product Characteristics
    ColorwhiteScore    
    ShapeOVALSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69316-321-1010 in 1 BOX11/10/2014
    11 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/10/2014
    Labeler - Damiva Inc. (203086327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acino Products, LLC019385518manufacture(69316-321)

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