Label: FLOREXA- eflornithine hydrochloride cream

  • NDC Code(s): 82160-125-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 11, 2021

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  • Composition

    Each 1 g contains: Eflornithine hydrochloride 139 mg.
    Excipients: Ceteareth-25, Cetostearyl alcohol, Lanolin, Glyceryl monostearate, mineral oil, Cetyl alcohol, Methyl Paraben, Emulsifying wax, Dimethicone, and Purified Water.

  • Properties

    Florexa is a prescribed medication applied to the skin for the reduction of unwanted facial hair in women.
    There are no studies examining the inhibition of the enzyme ornithine decarboxylase (ODC) in human skin following the application of topical eflornithine. However, there are studies in the literature that report the inhibition of ODC activity in skin following oral eflornithine. It is postulated that topical eflornithine hydrochloride irreversibly inhibits skin ODC activity. This enzyme is necessary in the synthesis of polyamines. Animal data indicate that inhibition of ornithine decarboxylase inhibits cell division and synthetic functions, which affect the rate of hair growth. Eflornithine hydrochloride Cream 13.9% has been shown to retard the rate of hair growth in non-clinical and clinical studies.

  • Indications

    Florexa is indicated for the reduction of unwanted facial hair in women. Florexa has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.

  • Contraindications

    Eflomithine HCl is contraindicated in patients with a history of sensitivity to any components of the preparation.
    Children less than 12 years of age shouldn't use Florexa.

  • Precautions

    For external use only.
    Transient stinging or burning may occur when applied to abraded or broken skin.

    Pregnancy

    Because there are no adequate and well-controlled studies in pregnant women, the risk / benefit ratio of using eflornithine HCl in women with unwanted facial hair who are pregnant should be weighed carefully with serious consideration for either not implementing or discontinuing use of Florexa.

    Lactation

    It is not known whether or not eflornithine hydrochloride is excreted in human milk. Caution should be exercised when Florexa is administered to a nursing woman.

  • Drug Interactions

    It is not known if Eflornithine HCl has any interaction with other topically applied drug products.

  • Warnings

    Discontinue use if hypersensitivity occurs.

  • Dosage and Administration

    Apply a thin layer of Florexa, to wanted areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. The patient should continue to use hair removal techniques as needed in conjunction with Florexa. ( Florexa should be applied at least 5 minutes after hair removal.) Cosmetics or sunscreens may be applied over treated areas; you should wait a few minutes to allow the treatment to be absorbed.


    Florexa doesn't permanently remove hair or "cure" unwanted facial hair. It is not a depilatory. Your treatment program should include continuation of any hair removal technique you are currently using. Florexa will help you manage your condition and improve your appearance.

    Improvement in the condition occurs gradually. Don't be discouraged if you see no immediate improvement. Be patient. Improvement may be seen as early as 4 to 8 weeks of treatment. Improvement may take longer in some individuals. If no improvement is seen after 6 months of use; discontinue use.

  • Overdosage

    Overdosage information is unavailable.

  • Side Effects

    The following side effects have been reported
    Acne, Pseudofolliculitis Barbae, Stinging Skin, Headache, Burning Skin, Dry Skin, Pruritus (itching), Erythema (redness), Tingling Skin, Dyspepsia, skin irritation, rash, alopecia, dizziness, folliculitis, hair ingrown, facial edema, anorexia, nausea, asthenia, vertigo.

  • Storage

    Store below 30 ºC.

  • How supplied

    30 g packs

  • THIS IS A MEDICAMENT

    • Medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you.
    • Strictly follow the doctor's prescription, the method of use and the instruction of the pharmacist who sold the medicament.
    • The doctor and the pharmacist are experts in medicine, its benefits and risks.
    • Do not by yourself interrupt the period of treatment prescribed for you.

    Do not repeat the same prescription without consulting your doctor.

    • Keep medicament out of reach of children.
  • Primary Package

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    FLOREXA 
    eflornithine hydrochloride cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:82160-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EFLORNITHINE HYDROCHLORIDE (UNII: 4NH22NDW9H) (EFLORNITHINE - UNII:ZQN1G5V6SR) EFLORNITHINE HYDROCHLORIDE ANHYDROUS41.7 mg  in 30 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-125-011 in 1 CARTON02/09/2012
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/09/2012
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)