Florexa

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2024-12-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
128
Source
full-release
Hydrated at
2026-05-31 21:21:18

Label at a glance#

ProductFlorexa
Active ingredientEFLORNITHINE HYDROCHLORIDE
Label structure15 sections

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.) Cosmeti...

Storage and handling

Store below 30 ºC.

Label contents#

Full prescribing information#

Composition

COMPONENTS

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

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

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

PRECAUTIONS SECTION

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

Pregnancy

PREGNANCY SECTION

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

LACTATION SECTION

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

DRUG INTERACTIONS SECTION

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

Warnings

WARNINGS SECTION

Discontinue use if hypersensitivity occurs.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Overdosage information is unavailable.

Side Effects

ADVERSE REACTIONS SECTION

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

STORAGE AND HANDLING SECTION

Store below 30 ºC.

How supplied

HOW SUPPLIED SECTION

30 g packs

THIS IS A MEDICAMENT

GENERAL PRECAUTIONS SECTION

  • 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EFLORNITHINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-125-01Florexa30 g in 1 TUBECREAM30128
82160-125-01Florexa1 in 1 CARTONCREAM1128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-125FLOREXA (EFLORNITHINE HYDROCHLORIDE) CREAM [PELLA PHARMACEUTICALS CO. LTD]128Legacy NDC, 2 package rows20250101_d0842c09-4f4f-5209-e053-2a95a90a54d6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-12582160-125-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
EFLORNITHINE HYDROCHLORIDE4NH22NDW9HACTIR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2a912c1b-7042-e496-e063-6294a90a532cd0842c09-4f4f-5209-e053-2a95a90a54d62024-12-31Warnings, Adverse reactionsExact identifier
spl id: 2a912c1b-7042-e496-e063-6294a90a532c
spl set id: d0842c09-4f4f-5209-e053-2a95a90a54d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.