Label: FEMICLEAR YEAST INFECTION- femiclear 2 day simple ointment

  • NDC Code(s): 71042-026-14
  • 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 November 8, 2023

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

  • Active Ingredients

    Calendula 2X HPUS

    Melaleuca 3X HPUS

    Olive Extract 3X HPUS

  • Purpose

    Healing agent

    Anti-yeast agent

    Anti-microbial and healing agent

  • Uses

    Treats vaginal yeast infections

  • Warnings

    For vaginal use only.

    FemiClear may damage condoms and diaphragms and cause them to fail

  • Ask a doctor before use if you have:

    vaginal itching and discomfort for the first time

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

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

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

  • Do not use

    if you are allergic to any ingredient in this product

  • When using this product

    do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted infections (STIs)

    do not have vaginal intercourse

    mild increase in vaginal burning, itching, or irritation may occur

    if you do not get complete relief, ask a doctor before using another product

  • Stop use and ask a doctor if

    symproms do not get better in 3 days

    symptoms last more than 7 days

    you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting or foul-smelling discharge

  • If pregnant or breastfeeding

    ask a healthcare 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 and children 12 years or over:

    Vaginal Ointment: use at bed time, read enclosed instructions for complete directions.

    to protect clothes, use panty liner.

    fill applicator with Vaginal Ointment - use one of the tubes

    lie down in bed. Insert applicator into vagina and inject FemiClear. Remain laying down to avoid leakage.

    discard applicator after use. DO NOT reuse.

    repeat on second night - use other tube.

    Children under 12 years: ask a doctor.

  • Other information

    do not use if applicator wrapper is torn, open or incompletely sealed

    do not use if seal over tube opening has been punctured

  • Other Information

    Store at 68-77 F (20 C - 25 C)

    If liquified, refrigerate 10 minutes to thicken.

  • Inactive ingredients

    beeswax, essential oil (natural fragrance), oxygenated olive oil

  • Questions?

    Call 512.401.3572 or vist femiclear.com. OrganiCare, LLC, Austin TX 78744, USA

  • SPL UNCLASSIFIED SECTION

    Made and Distributed by

    OrganiCare

    Austin, TX 78744 USA

  • PRINCIPAL DISPLAY PANEL

    Front Panel

    FemiClear

    Yeast Infection

    Relieves

    Itching

    Irritation

    Discharge

    Kills >99%

    of tough to treat

    yeast*

    *Laboratory testing (non-human/non-animal)

    Homeopathic Medicine

    2 Day Dose

    2 Tubes; Net Wt 0.25 oz

    (7.1G) each, Total Net Wt 0.5 oz (14.2G)

  • INGREDIENTS AND APPEARANCE
    FEMICLEAR YEAST INFECTION 
    femiclear 2 day simple ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE1 kg  in 1 kg
    CAJUPUT OIL (UNII: J3TO6BUQ37) (CAJUPUT OIL - UNII:J3TO6BUQ37) CAJUPUT OIL0.1 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    PEAR (UNII: 2ZN8DWC0YF)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-026-141 in 1 CARTON01/17/2023
    10.0142 kg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/17/2023
    Labeler - OrganiCare Nature's Science, LLC (044204745)
    Registrant - OrganiCare Nature's Science, LLC (044204745)
    Establishment
    NameAddressID/FEIBusiness Operations
    Organicare Nature's Science, LLC044204745manufacture(71042-026)