Label: OLIVE VAGINAL FORMULA- olive leaf vaginal spray spray

  • NDC Code(s): 64616-055-01, 64616-055-02
  • Packager: Vitality Works, Inc
  • 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 December 28, 2023

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  • Olive Vaginal Spray

    Borax 8X

    Helonius 8X

    Kreosotum 12X

    Platina 12X

  • Olive Vaginal Spray

    Extra Virgin Olive Oil, Natural Coconut Oil, Omega-3 Shark Liver Oil, vanilla fragrance, Natural Vitamin E

  • Olive Vaginal Spray

    Do not use if have never had a vaginal infection diagnosed by a doctor.

    Ask a doctor before use if you have:

    -vaginal itching and discomfort for the first time.

    -lower abdomina, back or shoulder pain, fever chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition

    -vaginal yeast infections ofter (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your syptoms, including diabetes or a weakened immune system.

    -been exposed to the human immunodeficiency virus (HIV) that causes AIDS.

  • Olive Vaginal Spray

    Keep out of reach of children. The ingredients in this product are 100% edible. However, this product is not meant to be swallowed. If swallowed, contact you doctor.

  • Olive Vaginal Spray

    A homeopathic remedy for the relief of vaginal irritations that can also be associatied with yeast, including external and internal itching & soreness, abnormal vaginal discharge, odor, redness and swelling.

  • Olive Vaginal Spray

    Adults and children 12 years of age and over:

    -Apply a drop of product to outside of tube to lubricate tube prior to insertion.

    -Insert applicator tube into vagina and apply 2-3 sprays in the morning and again at bedtime, for up to 10 days.

    -additional applications during the day can be applied as needed without any danger of overdose.

    -apply product while lying down to minimize leakage.

    -after each use, wash applicator tube in warm soapy water or replace with a new one.

    Children under 12 years of age, ask a doctor.

  • Olive Vaginal Spray

    Borax - Leucorrhoea like white of egg; pruritius of vulva and eczema; Urine strong smelling; Acrid leucorrhea, unnaturally hot with swelling of labia.

    Helonius - Pruritus vulvae; leucorrhoea; parts hot, red and swollen, burn and itch terribly. Intense pruritus, vulvar and vaginal, labia and adjoining skin red and swollen. 

    Kreosotum - Excoriating, buring and offensive discharges; offensive urine; violent itching of vulva and vagina; burnign and welling of labia; leucorrhoea yellow, acrid.

    Platina - Female parts hypersensitive; excessive itching in uterus; Leucorrhea like white of eggs.

  • Olive Vaginal Spray

    Label

    Carton

  • INGREDIENTS AND APPEARANCE
    OLIVE VAGINAL FORMULA 
    olive leaf vaginal spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-055
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE8 [hp_X]  in 1 mL
    CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT8 [hp_X]  in 1 mL
    WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE12 [hp_X]  in 1 mL
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-055-021 in 1 CARTON02/10/2010
    1NDC:64616-055-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/10/2010
    Labeler - Vitality Works, Inc (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-055)