Label: FEMICLEAR 2 DAY- olive extract, calendula, melaleuca ointment

  • NDC Code(s): 71042-005-28
  • Packager: OrganiCare Nature's Science, LLC
  • 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 October 2, 2018

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Calendula 3X HPUS

    Melaleuca 3X HPUS

    Olive Extract 2X HPUS

  • PURPOSE

    Purposes

    Healing Agent

    Anti-Yeast Agent

    Antimicrobial and Healing Agent

  • INDICATIONS & USAGE

    Uses

    See your doctor if this is the first time you have vaginal itching and discomfort to find out if you have a vaginal yeast infection.

    • Treats repeat vaginal yeast infections
    • To relieve external itching and irritation due to a repeat vaginal yeast infection
  • WARNINGS

    Warnings

    For vaginal use only.

    FemiClear may damage condoms and diaphragms and cause them to fail.

  • ASK DOCTOR

    Ask a doctor before use if you:

    • Have 1 or more of the following: abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge
    • Get vaginal yeast infections often (such as once a month or three in 6 months)
    • May have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
    • Are under 12 years of age.
  • WHEN USING

    When using this product

    • Do not have vaginal intercourse
    • Do not use tampons, douches, spermicides, or other vaginal products
  • STOP USE

    Stop use and ask a doctor if

    • Symptoms do not improve in 3 days
    • Symptoms remain after 7 days
    • You get abdominal pain, fever, chills, vomiting, foul-smelling discharge, or hives
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Before using this product, read the enclosed consumer instructions for use for complete directions and information.
    • Adults and children 12 years old and older:
    • Fill applicator with Femi-Clear Vaginal Ointment as shown
    • Insert applicator into the vagina at bedtime for 2 nights in a row. Discard applicator after each use.
    • External itch cream: Squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use as needed.
    • Children under 12 years old: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at 68° to 77°F (20° to 25°C)
    • if liquefied, refrigerate 10 minutes to thicken
  • INACTIVE INGREDIENT

    Inactive ingredients

    oxygenated olive oil, pure essential oil (lavender)

  • QUESTIONS

    Questions?

    Call 512-401-3572 or

    Visit FemiClear.com

  • SPL UNCLASSIFIED SECTION

    Distributed by

    OrganiCare®

    Austin, TX 78744

    Made in Italy

  • PRINCIPAL DISPLAY PANEL

    MADE WITH ORGANIC INGREDIENTS

    NO Artificial Antifungal Drugs or Chemicals

    Fast Symptom Relief.

    FemiClear

    All-Natural and Organic

    A homeopathic medicine that eliminates most vaginal yeast infections

    Made from oxygenated olive oil, calendula and melaleuca

    2 Day Dose

    NET WT 1 oz (28.4 g)

    71042-005-28

  • INGREDIENTS AND APPEARANCE
    FEMICLEAR  2 DAY
    olive extract, calendula, melaleuca ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-005
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU) MELALEUCA CAJUPUTI LEAF OIL3 [hp_X]  in 28 g
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J) OLEA EUROPAEA FRUIT VOLATILE OIL2 [hp_X]  in 28 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-005-281 in 1 CARTON12/20/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2017
    Labeler - OrganiCare Nature's Science, LLC (044204745)
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