Label: FLUOPAR- fluocinonide, dimethicone kit

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively. See full prescribing information for Fluocinonide Cream USP, 0.1%.

Fluocinonide Cream USP, 0.1%
For topical use
Initial U.S. Approval: 1971

Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.

Limitation of Use:

• Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1)
• Avoid use on the face, groin, or axillae. (1.2)
• Avoid use in perioral dermatitis or rosacea.

For topical use only. Fluocinonide Cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use.

Psoriasis: apply a thin layer once or twice daily to the affected skin areas.

Atopic Dermatitis: apply a thin layer once daily to the affected skin areas.

Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis:

apply a thin layer once or twice daily to the affected areas.

Cream, 0.1% (3)

Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg of fluocinonide in a white to off-white cream base.

None.

•Fluocinonide Cream USP, 0.1% has been shown to suppress the HPA axis. Systemic absorption of Fluocinonide Cream USP, 0.1% may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia and unmask latent diabetes (5.1)
•Systemic absorption may require evaluation for HPA axis suppression (5.1)
•Modify use should HPA axis suppression develop (5.1)
•Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption (5.3)
•Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids (5.3)
•Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)

The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion.

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Topically applied Fluocinonide Cream USP, 0.1% can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52.

It has the following chemical structure:

Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol.

Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water.

Two adequate and well-controlled efficacy and safety studies of fluocinonide cream, 0.1% have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with fluocinonide cream, 0.1% for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.

Table 2: Plaque-type Psoriasis in Adults

*Cleared or almost cleared

Table 3: Atopic Dermatitis in Adults

*Cleared or almost cleared

No efficacy studies have been conducted to compare fluocinonide cream, 0.1% with any other topical corticosteroid product, including fluocinonide cream 0.05%.

Fluocinonide Cream USP, 0.1% is white to off-white in color and is supplied in tubes as follows:

30 g (NDC 45802- 151-94)

60 g (NDC 45802- 151-96)

120 g (NDC 45802- 151-53)

Store at controlled room temperature: 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Keep the tube tightly closed.

[See FDA-approved patient labeling (Patient Information)]

Patients using Fluocinonide Cream USP, 0.1% should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:

• Fluocinonide Cream USP, 0.1% is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. It should not be used on the face, groin, and underarms.
• Fluocinonide Cream USP, 0.1% should not be used for any disorder other than that for which it was prescribed.
•The treated skin area should not be bandaged or otherwise covered or wrapped, so as to be occlusive unless directed by the physician.
• Patients should report to their physician any signs of local adverse reactions.
• Other corticosteroid-containing products should not be used with Fluocinonide Cream USP, 0.1% without first talking to the physician.
• As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen in 2 weeks, the patient should be instructed to contact a physician. The safety of the use of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established.
• Patients should be informed to not use more than 60 g per week of Fluocinonide Cream USP, 0.1%. Do not use more than half of the 120 g tube per week.
• Patients should inform their physicians that they are using Fluocinonide Cream USP, 0.1% if surgery is contemplated.
• Patients should wash their hands after applying medication.

Rx Only

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010

www.perrigo.com

Rev 01-19

1M100 RC J5

Fluocinonide Cream USP, 0.1%

Important: For skin use only. Do not get Fluocinonide Cream USP, 0.1% in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

Read the Patient Information that comes with Fluocinonide Cream USP, 0.1% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.

What is Fluocinonide Cream USP, 0.1%?

Fluocinonide Cream USP, 0.1% is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.

• You should not use Fluocinonide Cream USP, 0.1% for longer than 2 weeks in a row.
• You should not use more than 60 grams of Fluocinonide Cream USP, 0.1% or more than half of the 120 gram tube in 1 week.
• Fluocinonide Cream USP, 0.1% should not be used:

•if you have skin swelling or redness on the nose of face (rosacea)
• for a scaly or bumpy rash around your mouth (perioral dermatitis)
• on your face, underarms, or groin area

It is not known if Fluocinonide Cream USP, 0.1% is safe and effective in children under 12 years of age.

What should I tell my doctor before using Fluocinonide Cream USP, 0.1%?

Before using Fluocinonide Cream USP, 0.1% , tell your doctor if you:

•have had irritation or other skin reaction to a steroid medicine in the past
•have adrenal gland problems
•plan to have surgery
•are pregnant or plan to become pregnant. It is not known if Fluocinonide Cream USP, 0.1% will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
•are breast-feeding or plan to breastfeed. It is not known if Fluocinonide Cream USP, 0.1% passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Fluocinonide Cream USP, 0.1%

.

Tell your doctor about all the medicine you take including prescriptions and non-prescriptions medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I use Fluocinonide Cream USP, 0.1%?

• See “What is Fluocinonide Cream USP, 0.1%?”
• Use Fluocinonide Cream USP, 0.1% exactly as your doctor tells you.
• This medicine is for use on the skin only. Do not use Fluocinonide Cream USP, 0.1% in your eyes, mouth or vagina.
• Wash your hands after you use Fluocinonide Cream USP, 0.1%.
• Do not use Fluocinonide Cream USP, 0.1% for longer than 2 weeks in a row.
• Talk to your doctor if your skin does not get better after 2 weeks of treatment with Fluocinonide Cream USP, 0.1% .
• Do not bandage or cover the skin treated with Fluocinonide Cream USP, 0.1% unless your doctor tells you to.

What are the possible side effects with Fluocinonide Cream USP, 0.1%?

Fluocinonide Cream USP, 0.1% may cause side effects, including:

• Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using Fluocinonide Cream USP, 0.1% . Tell your doctor if you have any of these symptoms of adrenal insufficiency:
• tiredness that worsens and does not go away
• nausea or vomiting
• dizziness or fainting
• muscle weakness
• irritability and depression
• loss of appetite
• weight loss
• Cushing’s syndrome, when the body is exposed to too much of the hormone cortisol.

Your doctor may do tests to check for this. Symptoms can include:

• weight gain, especially around your upper back and midsection
• slow healing of cuts, insect bites and infections
• tiredness and muscle weakness
• depression, anxiety and irritability
• roundness of your face (moon face)
• new or worsening high blood pressure

The most common side effect of Fluocinonide Cream USP, 0.1% is burning of your skin treated with Fluocinonide Cream USP, 0.1%.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with Fluocinonide Cream USP, 0.1%. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Perrigo at 1-866-634-9120.

How should I store Fluocinonide Cream USP, 0.1%?

• Store Fluocinonide Cream USP, 0.1% at room temperature, between 20-25°C (68-77°F) [see USP Controlled Room Temperature].
• Keep the tube tightly closed.

Keep Fluocinonide Cream USP, 0.1% and all medicines out of the reach of children.

General information about Fluocinonide Cream USP, 0.1%

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Fluocinonide Cream USP, 0.1% for a condition for which it was not prescribed. Do not give Fluocinonide Cream USP, 0.1% to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Fluocinonide Cream USP, 0.1% . If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Fluocinonide Cream USP, 0.1% that is written for healthcare professionals.

What are the ingredients in Fluocinonide Cream USP, 0.1%?

Active ingredient: fluocinonide 0.1%

Inactive ingredients: carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Rx Only

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010

www.perrigo.com

Rev 01-19

1M100 RC J5

Drug Facts

Dimethicone 5.0%

Skin Protectant

■ for the treatment and/or prevention of diaper rash
■ temporarily protects and helps relieve chapped or cracked skin

For external use only

Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns

When using this product ■ do not get into eyes

Stop use and ask a doctor if ■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

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

■ apply cream liberally as needed

■ protect from freezing ■ avoid excessive heat

Aleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex® [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG100 stearate, pentaerythrityl tetraditbutyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine.

Rx Only

Fluocinonide Cream USP, 0.1%

For Topical Use Only. Not for Ophthalmic, Oral, or Intravaginal Use.

NET WT 30 g

NDC 59088-746-00

DermacinRx® Fluorpar™ [Fluocinonide Cream USP, 0.1% and Skin Repair Complex (Dimethicone Cream 5%)]

Rx only

Packaged in the USA by:
PureTek Corporation, Panorama City, CA 91402 USA

For question or information, call toll-free: 877-921-7873