FEMICLEAR 2 DAY (OLIVE EXTRACT, CALENDULA, MELALEUCA) OINTMENT [ORGANICARE NATURE'S SCIENCE, LLC]

FEMICLEAR 2 DAY (OLIVE EXTRACT, CALENDULA, MELALEUCA) OINTMENT [ORGANICARE NATURE'S SCIENCE, LLC]
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NDC 71042-005-28
Set ID 60cccf41-3534-3cfb-e053-2991aa0a1e04
Category HUMAN OTC DRUG LABEL
Packager OrganiCare Nature's Science, LLC
Generic Name
Product Class
Product Number
Application Number
  • 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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