Label: FEMICLEAR YEAST INFECTION TREATMENT- calendula, melaleuca, oleuropein, chamomilla kit

  • NDC Code(s): 71042-011-28, 71042-012-14, 71042-013-14
  • 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 December 12, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Vaginal Ointment

    Calendula 3X HPUS

    Melaleuca 3X HPUS

    Olive Extract (Oleuropein) 3X HPUS

    Itch Relief

    Chamomilla 3X HPUS

    Olive Extract (Oleuropein) 3X HPUS

  • PURPOSE

    Purposes

    Healing agent

    Anti-yeast agent

    Antimicrobial and healing agent

    Anti-itch and inflammatory agent

    Anti-microbial and healing agent

  • INDICATIONS & USAGE

    Uses

    • treats vaginal yeast infections
    • relieves external itching and irritation due to a vaginal yeast infection
  • WARNINGS

    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 DOCTOR

    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 three 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

    When using this product

    • do not use tampons, douiches, 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

    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

    • Adults and children 12 years or over:

    ​Vaginal Ointment: use at bedtime, read enclosed instructions for complete directions.

    • to protect clothes, use panty liner
    • fill applicator with FemiClear Vaginal Ointment (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.

    Itch Relief: squeeze ointment onto fingertips. Apply onto itchy, irritated skin outside the vagina (vulva) as needed.

    • Children under 12 years: ask a doctor
  • STORAGE AND HANDLING

    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 (20-25°C). If liquified, 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 INGREDIENT

    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

  • SPL UNCLASSIFIED SECTION

    Made and Distributed by

    OrganiCare®

    Austin, TX 78744, USA

  • SPL UNCLASSIFIED SECTION

    Claims based on clinical and/or in vitro laboratory (non-human/non-animal) studies, and traditional homeopathic practice (not accepted clinical medical evidence; not FDA evaluated). See FemiClear.com.

  • PRINCIPAL DISPLAY PANEL

    FemiClear Kit Nov 2021 PDP

  • INGREDIENTS AND APPEARANCE
    FEMICLEAR   YEAST INFECTION TREATMENT
    calendula, melaleuca, oleuropein, chamomilla kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-011
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-011-281 in 1 CARTON; Type 0: Not a Combination Product11/12/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 14 g
    Part 21 TUBE 14 g
    Part 1 of 2
    FEMICLEAR VAGINAL 
    calendula, melaleuca, oleuropein ointment
    Product Information
    Item Code (Source)NDC:71042-012
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 14 g
    OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN3 [hp_X]  in 14 g
    MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU) MELALEUCA CAJUPUTI LEAF OIL3 [hp_X]  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-012-1414 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/12/2021
    Part 2 of 2
    FEMICLEAR EXTERNAL ANTI-ITCH 
    chamomilla, oleuropein ointment
    Product Information
    Item Code (Source)NDC:71042-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLEUROPEIN (UNII: 2O4553545L) (OLEUROPEIN - UNII:2O4553545L) OLEUROPEIN3 [hp_X]  in 14 g
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    OATMEAL (UNII: 8PI54V663Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-013-1414 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/12/2021
    Labeler - Organicare Nature's Science, LLC (044204745)
    Establishment
    NameAddressID/FEIBusiness Operations
    Organicare Nature's Science, LLC044204745manufacture(71042-011)