Label: FEMICLEAR INFECTION PROTECTION- vaginal cream cream

  • NDC Code(s): 71042-028-14
  • 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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  • ACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

    This product is intended to help prevent bacterial vaginosis (BV) and
    yeast infections, and to moisturize.

  • WARNINGS

    For vaginal 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 a latex or polyurethane condom to
    reduce the risk of getting STIs.
    FemiClear does not eliminate the risk of infections.

  • DO NOT USE

    if you are allergic to any ingredient in this product

  • WHEN USING

     can be used in combination with other medications, please consult a
    healthcare professional
     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).

  • STOP USE

     rash or allergic reaction develops
     vaginal symptoms develop  you get a rash or hives, abdominal
    pain, fever, chills, nausea or vomiting

  • PREGNANCY OR BREAST FEEDING

    ask a healthcare professional before use.

  • ASK DOCTOR

     rash or allergic reaction develops
     vaginal symptoms develop  you get a rash or hives, abdominal
    pain, fever, chills, nausea or vomiting

  • DOSAGE & ADMINISTRATION

    Directions
     Adults and children 12 years or over:
     Wash hands before and after use.
     Squeeze desired amount into applicator.
     Insert applicator into vagina and inject cream.
     Clean applicator after use and reuse.
     Children under 12 years: ask a doctor

  • OTHER SAFETY INFORMATION

     do not use if applicator wrapper is torn, open or incompletely sealed
     do not use if seal over tube opening has been punctured
     Store at 68° – 77° F (20° C – 25° C)

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Call 512.401.3572 or visit femiclear.com.

  • KEEP OUT OF REACH OF CHILDREN

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

  • PURPOSE

    This product is intended to help prevent bacterial vaginosis (BV) and
    yeast infections, and to moisturize.

  • PRINCIPAL DISPLAY PANEL

    FemiClear Vulva Cream

  • INGREDIENTS AND APPEARANCE
    FEMICLEAR INFECTION PROTECTION 
    vaginal cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71042-028
    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 1 g
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONIC ACID (NON-ANIMAL STABILIZED) (UNII: B7SG5YV2SI)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71042-028-141 in 1 CARTON08/07/2023
    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 homeopathic08/07/2023
    Labeler - OrganiCare Nature's Science, LLC (044204745)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrganiCare Nature's Science044204745manufacture(71042-028)
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