Label: FEMICLEAR 2 DAY GENTLE- 2 day yeast infection gentle ointment

  • NDC Code(s): 71042-029-14
  • 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 October 12, 2023

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

  • Active Ingredients

    Active ingredients
    Vaginal Ointment
    Calendula 6X HPUS ............................................................................................... Healing agent
    Melaleuca 6X HPUS........................................................................................... Anti-yeast agent
    Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent
    Itch Relief
    Chamomilla 3X HPUS ............................................................... Anti-itch and inflammatory agent
    Olive Extract (Oleuropein) 3X HPUS ............................................Anti-microbial and healing agent

  • Warnings

    For vaginal use only.
    Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
    FemiClear may damage condoms and diaphragms and cause them to fail.

  • Ask a doctor before use if you have:

    Ask a doctor before use if you have:
     vaginal itching and discomfort for the first time
     lower abdominal, back or shoulder pain, 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

    Do not use
     if you are allergic to any ingredient in this product

  • When using 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

  • Warnings (Cont.)

    Stop use and ask a doctor if
     symptoms 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 breast-feeding

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

  • Keep out of the reach of children

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

  • Directions

    Directions
     Adults and children 12 years or over:
    Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
    complete directions.
     to protect clothes, use panty liner.
     fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the pink tube
     lie down in bed. Insert applicator into vagina and inject FemiClear. Remain lying
    down to avoid leakage.
     discard applicator after use. DO NOT reuse.
     repeat on second night - use other 1/2 of the pink tube
    Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
    outside the vagina (vulva) as needed.
     Children under 12 years: ask a doctor

  • Other information

    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
     do not purchase if carton is open
     Store at 68° – 77° F (20° C – 25° C) If liquefied, refrigerate 10 minutes to thicken.
     this a 2-dose treatment. Most women do not get complete relief of their symptoms in
    just 2 days. Most women get some improvement in 2 days and complete relief by 7 days.

  • Inactive ingredients

    Inactive ingredients
    Vaginal Ointment: beeswax, essential oil (natural fragrance), oxygenated olive oil
    Itch Relief: beeswax, colloidal oatmeal, essential oil (natural fragrance),
    oxygenated olive oil

  • Questions

    Questions?
    Call 512.401.3572 or visit femiclear.com. OrganiCare, LLC, Austin, TX 78744, USA

  • Uses

    -treats vaginal infections

    -releaves external itching and irritation due to vaginal yeast inrfection

    -relieves external itching and irritation due to vaginal yeast inrfection

  • Directions

    Directions
     Adults and children 12 years or over:
    Vaginal Ointment (pink tube): use at bed time, read enclosed instructions for
    complete directions.
     to protect clothes, use panty liner.
     fill applicator with Vaginal Ointment (pink tube) - use 1/2 of the pink tube
     lie down in bed. Insert applicator into vagina and inject FemiClear. Remain lying
    down to avoid leakage.
     discard applicator after use. DO NOT reuse.
     repeat on second night - use other 1/2 of the pink tube
    Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin
    outside the vagina (vulva) as needed.
     Children under 12 years: ask a doctor

  • PRINCIPAL DISPLAY PANEL

    2 Day Gentle Carton

  • INGREDIENTS AND APPEARANCE
    FEMICLEAR 2 DAY GENTLE 
    2 day yeast infection gentle ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELALEUCA CAJUPUTI WHOLE (UNII: K62C66D9LN) (MELALEUCA CAJUPUTI WHOLE - UNII:K62C66D9LN) MELALEUCA CAJUPUTI WHOLE0.01 g  in 100 g
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E) 88 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-029-141 in 1 CARTON07/28/2023
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/28/2023
    Labeler - OrganiCare Nature's Science, LLC (044204745)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrganiCare Nature's Science, LLC044204745manufacture(71042-029)