PRECAUTIONS SECTION.

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 nursing woman.

ADVERSE REACTIONS SECTION.

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.

COMPONENTS.

Composition Each 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.

CONTRAINDICATIONS SECTION.

Contraindications Eflomithine HCl is contraindicated in patients with history of sensitivity to any components of the preparation. Children less than 12 years of age shouldnt use Florexa.

DESCRIPTION SECTION.

Properties Florexa is 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.

DOSAGE & ADMINISTRATION SECTION.

Dosage and Administration Apply 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 hours. Use twice daily at least hours apart or as directed by physician. The patient should continue to use hair removal techniques as needed in conjunction with Florexa. Florexa should be applied at least minutes after hair removal.) Cosmetics or sunscreens may be applied over treated areas; you should wait few minutes to allow the treatment to be absorbed. Florexa doesnt permanently remove hair or cure unwanted facial hair. It is not 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. Dont be discouraged if you see no immediate improvement. Be patient. Improvement may be seen as early as to weeks of treatment. Improvement may take longer in some individuals. If no improvement is seen after months of use; discontinue use.

DRUG INTERACTIONS SECTION.

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

GENERAL PRECAUTIONS SECTION.

THIS IS MEDICAMENT Medicament is product which affects your health and its consumption contrary to instructions is dangerous for you. Strictly follow the doctors 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.. Medicament is product which affects your health and its consumption contrary to instructions is dangerous for you. Strictly follow the doctors 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.. Keep medicament out of reach of children.

INDICATIONS & USAGE SECTION.

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.

LACTATION SECTION.

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

PREGNANCY SECTION.

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.