Label: FEMICLEAR VULVA CREAM cream

  • NDC Code(s): 71042-027-14
  • 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

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  • WARNINGS

    For external use only.

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

    FemiClear does not prevent sexually transmitted infections (STIs). Practice safer sex by using latex or polyurethane condom to reduce the risk of getting STIs.

    FemiClear does not eliminate the risk of infections.

     if you are allergic to any ingredient in this product

     do not use in or near the eyes

    Stop use and ask a doctor if  rash or allergic reaction
    develops  vaginal symptoms develop  you get a rash or
    hives, abdominal pain, fever, chills, nausea or vomiting

    If pregnant or breast-feeding, 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.

  • ACTIVE INGREDIENT

    Melaleuca 6X HPUS................................................ Anti-yeast agent
    Olive Extract (Oleuropein) 5X HPUS ...Anti-microbial and healing agent
    Thymol 6X HPUS................................................Anti-bacterial agent

  • INACTIVE INGREDIENT

    Water, Oxygenated Olive Oil, essential oil (natural fragrance),
    Cetearyl Olivate, Sorbitan Olivate, Xanthan Gum, Cetyl Esters,
    Castor Seed Oil, Hydrogenated Castor Oil, Carnauba Wax, Phenethyl
    Alcohol, Pentylene Glycol, Hyaluronic Acid

  • QUESTIONS

    Questions?
    Call 512.401.3572 or visit femiclear.com

  • DOSAGE & ADMINISTRATION

    Squeeze onto fingertip and apply generously all over vulva including urethra. Ues as often as needed.

  • INDICATIONS & USAGE

    Use as often as needed.

  • PURPOSE

    This product is intended to help prevent urinary tract infections (UTIs) and moisturize.

  • PRINCIPAL DISPLAY PANEL

    FemiClear Vulva Cream

  • INGREDIENTS AND APPEARANCE
    FEMICLEAR VULVA CREAM 
    femiclear vulva cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.0001 kg  in 100 kg
    MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU) (MELALEUCA CAJUPUTI LEAF OIL - UNII:5O59RMR6DU) MELALEUCA CAJUPUTI LEAF OIL0.0001 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) 1 kg  in 100 kg
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.5 kg  in 100 kg
    XANTHAN GUM (UNII: TTV12P4NEE) 0.2 kg  in 100 kg
    PENTYLENE GLYCOL (UNII: 50C1307PZG) 2 kg  in 100 kg
    CETYL ESTERS WAX (UNII: D072FFP9GU) 6 kg  in 100 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-027-141 in 1 CARTON07/17/2023
    10.142 kg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/17/2023
    Labeler - OrganiCare Nature's Science, LLC (044204745)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrganiCare Nature's Science, LLC044204745manufacture(71042-027)
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