Label: NATURAL VAGINAL CARE- sambucus nigra flower, echinacea purpurea, and centella asiatica cream

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 27, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 2.5 g)Purposes
    • Sambucus nigra 2xIrritation reducer
    tissue repair formula
    • Echinacea purpurea 3xIrritation reducer
    • Hydrocotyle asiatica 3xIrritation reducer
  • Uses

    • relieves vaginal pain, itching, burning and discomfort
  • Warnings

    For vaginal use only.

    When using this product

    • do not use tampons, douches or other vaginal products
    • do not exceed the recommended dosage unless directed by a physician

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days

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

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Insert 1 applicatorful (2.5cc) into the vagina at bedtime for 14 consecutive nights.

    Afterwards apply 3 times a week or as needed. Wash applicator after use.

  • Other Information

    • do not use if seal over tube opening has been punctured
    • do not purchase if carton is open
    • store at 20-25°C (68 to 77°F)
    • keep out of direct sunlight
  • Inactive Ingredients

    cetyl alcohol, cetyl palmitate, disodium EDTA, hypromellose, methylparaben, polysorbate 60, propylene glycol, silicon dioxide, stearyl alcohol, white petrolatum, water

  • Questions?

    Call 1-800-956-2595 Monday thru Friday 8am - 5pm EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: Izun Pharmaceuticals Corp.
    New York, NY 10022 USA

  • PRINCIPAL DISPLAY PANEL - 39.7 g Tube Carton

    Herbal Formula
    Natural BioActives
    NDC 49589-115-60

    Natural Vaginal Care

    Vaginal Cream

    Relieves Vaginal Pain, Itching,
    Burning & Discomfort

    • Fast Acting Relief
    • Soothing Herbal Formula
    • Package includes
      3 reusable applicators

    NET WT
    1.4 OZ
    (39.7 g)

    Homeopathic

    izun
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 39.7 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NATURAL VAGINAL CARE 
    sambucus nigra flower, echinacea purpurea, and centella asiatica cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49589-115
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sambucus nigra flower (UNII: 07V4DX094T) (Sambucus nigra flower - UNII:07V4DX094T) Sambucus nigra flower2 [hp_X]  in 2.5 g
    Echinacea purpurea (UNII: QI7G114Y98) (Echinacea purpurea - UNII:QI7G114Y98) Echinacea purpurea3 [hp_X]  in 2.5 g
    Centella Asiatica (UNII: 7M867G6T1U) (Centella Asiatica - UNII:7M867G6T1U) Centella Asiatica3 [hp_X]  in 2.5 g
    Inactive Ingredients
    Ingredient NameStrength
    cetyl alcohol (UNII: 936JST6JCN)  
    cetyl palmitate (UNII: 5ZA2S6B08X)  
    edetate disodium (UNII: 7FLD91C86K)  
    hypromellose 2208 (15000 mpa.s) (UNII: Z78RG6M2N2)  
    methylparaben (UNII: A2I8C7HI9T)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    propylene glycol (UNII: 6DC9Q167V3)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    petrolatum (UNII: 4T6H12BN9U)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49589-115-601 in 1 CARTON
    140 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC05/29/2015
    Labeler - Izun Pharmaceuticals Corporation (624194523)
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