VAGICAL (CALENDULA OFFICINALIS FLOWERING TOP) INSERT [FARMINA SP. Z O.O.]

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VAGICAL (CALENDULA OFFICINALIS FLOWERING TOP) INSERT [FARMINA SP. Z O.O.]
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NDC 68984-001-10
Set ID 0ab35c03-942e-4ba5-ba5a-65c5a99830d7
Category HUMAN OTC DRUG LABEL
Packager Farmina sp. z o.o.
Generic Name
Product Class
Product Number
Application Number
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  • Vagical

  • Active ingredient

    Calendula officinalis TINC HPUS*

    *The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • Purpose

    Healing agent and anti-inflammatory

  • Uses

    For temporary relief of minor symptoms of vaginitis, such as itching, burning and irritation.

  • Warnings

    For vaginal use only

    Do not use

    • if you are allergic (hypersensitive) to any of the ingredients found in the insert
    • after expiration date on carton

    Ask a doctor before use if you have

    • strong vaginal discharge
    • vaginal bleeding

    Ask a doctor or pharmacist before use if you are presently taking other vaginal insert drug products

    When using this product do not exceed recommended dose.

    Stop use and ask a doctor if

    • no improvement is seen after three to four days
    • your symptoms worsen
    • you experience irritation from using the product

    If pregnant or breastfeeding, ask a health professional before use.

  • Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults 18 years and up: Wash hands before and after use. Before use, damp insert with water that has been previously boiled and cooled. Place one insert into vagina 2-3 times per day.
    • Children 12-18 years: Consult a doctor before use.
    • Under 12 years of age: Do not use
  • Other information

    do not store above 77 degrees F (25 degrees C)

  • Inactive ingredient

    Polyethylene Glycol.

  • Vagical 10 Count (68984-001-10)

    Vagical

  • INGREDIENTS AND APPEARANCE
    VAGICAL 
    calendula officinalis flowering top insert
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68984-001
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP150 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68984-001-1010 in 1 PACKAGE; Type 0: Not a Combination Product05/29/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2014
    Labeler - Farmina sp. z o.o. (422254391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farmina sp. z o.o.422254391manufacture(68984-001)
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