FLOREXA- eflornithine hydrochloride cream 
Pella Pharmaceuticals Co. Ltd

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.

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Florexa

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

Do not repeat the same prescription without consulting your doctor.

Primary Package

Primary Package

Secondary Package

Secondary Package

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 ANHYDROUS4170 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)

Revised: 12/2023
Document Id: 0d6dea2d-dc2e-5a71-e063-6394a90a4a26
Set id: d0842c09-4f4f-5209-e053-2a95a90a54d6
Version: 127
Effective Time: 20231226
 
Pella Pharmaceuticals Co. Ltd