Label: FEMICLEAR VAGINAL ITCH RELIEF- chamomilla, olive extract ointment

  • NDC Code(s): 71042-010-14
  • 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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Chamomilla 3X HPUS

    Olive Extract 2X HPUS

  • PURPOSE

    Purpose

    Anti-itch and anti-inflammatory agent

    Antimicrobial and healing agent

  • INDICATIONS & USAGE

    Use

    Temporarily relieves external feminine itching

  • WARNINGS

    Warnings

    For external use.

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

    Do not use

    • if you have a vaginal discharge. Consult a doctor.
    • if you are allergic to any of the ingredients

    When using this product

    • avoid contact with the eyes

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
    • rash or other allergic reaction develops
  • 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 of age and olderApply a fingertip amount to affected area as needed.
    children under 12 yearsconsult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Beeswax, colloidal oatmeal, essential oil (fragrance), oxygenated olive oil

  • QUESTIONS

    Questions? Call 512.401.3572 or visit femiclear.com

  • SPL UNCLASSIFIED SECTION

    Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

    Made and Distributed by

    Organicare

    Austin, TX 78744, USA

  • PRINCIPAL DISPLAY PANEL

    MADE WITH ORGANIC INGREDIENTS

    No Artificial Chemicals or Steroids

    MAXIMUM STRENGTH

    FAST FEMININE ITCH RELIEF

    ♦ ITCHING ♦ BURNING ♦ IRRITATION

    FemiClear®

    Vaginal Itch Relief

    Homeopathic Medicine

    Net Wt. 0.5 oz (14.2 g)

    Femiclear Oatmeal Ver 3

  • INGREDIENTS AND APPEARANCE
    FEMICLEAR   VAGINAL ITCH RELIEF
    chamomilla, olive extract ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE3 [hp_X]  in 14 g
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) (OLEA EUROPAEA FRUIT VOLATILE OIL - UNII:8E7358CX1J) OLEA EUROPAEA FRUIT VOLATILE OIL2 [hp_X]  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    OATMEAL (UNII: 8PI54V663Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-010-141 in 1 CARTON02/20/2020
    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 homeopathic02/20/2020
    Labeler - Organicare Nature's Science, LLC (044204745)
    Establishment
    NameAddressID/FEIBusiness Operations
    Organicare Nature's Science, LLC044204745manufacture(71042-010)
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