CLOBETASOL PROPIONATE (Page 3 of 4)

14.2 Non-scalp Psoriasis

Another well-controlled clinical trial evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean body surface area at baseline was 6.7% with a range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for 2 weeks with clobetasol propionate foam or vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of clobetasol propionate foam in treating non-scalp psoriasis at the end of 2 weeks’ treatment was superior to that of vehicle foam (Table 3).

Table 3. Efficacy Results From a Controlled Clinical Trial in Non-scalp Psoriasis

a Defined as a composite of a Physician’s Static Global Assessment score of 0 or 1, scaling score of 0 or 1, an erythema score of 0 or 1 and a plaque thickness score of 0, based on a severity scale of 0 to 5 at endpoint.
	Clobetasol Propionate Foam n (%)	Vehicle Foam n (%)
Total number of subjects	139	140
Subjects with treatment successa	39 (28)	4 (3)
Physician’s Static Global Assessment -Clear or almost clear at endpoint	94 (68)	30 (21)
Scaling — Clear or almost clear at endpoint	101 (73)	42 (30)
Erythema — Clear or almost clear at endpoint	88 (63)	35 (25)
Plaque Thickness — Clear at endpoint	44 (32)	5 (4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Clobetasol propionate foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white to off white foam is available as follows:

Strength	NDC Number
50 g aluminum can	NDC 71589-018-50
100 g aluminum can	NDC 71589-018-31

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Effects on Endocrine System

Clobetasol propionate foam may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including clobetasol propionate foam, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using Clobetasol propionate foam if surgery is contemplated [see Warnings and Precautions (5.1)].

Ophthalmic Adverse Reactions

Advise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.2)].

Local Adverse Reactions

Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use [see Warnings and Precautions (5.3)].

Pregnancy

Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)].

Lactation

Advise a woman to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clobetasol propionate foam directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].

Important Administration Instructions

Inform patients of the following:

• Avoid use of clobetasol propionate foam on the face, underarms, or groin areas unless directed by the physician.
• Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
• Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
• For proper dispensing of foam, hold the can upside down and depress the actuator. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin.
• Limit treatment to 2 consecutive weeks. Use no more than 50 grams of clobetasol propionate foam per week, or more than 21 capfuls per week.
• Avoid use of clobetasol propionate foam in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
• The product is flammable; avoid heat, flame, and smoking when applying this product.
• Do not use other corticosteroid-containing products without first consulting with the physician.

Manufactured for:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

Manufactured by:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

Mfg. license No.: G/25/2216

For additional information, call FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Patient Information Clobetasol Propionate (kloe bay’ ta sol proe’ pee oh nate) Foam, 0.05%

Important: Clobetasol propionate foam is for use on the skin only. Do not get clobetasol propionate foam in your eyes, mouth, or vagina.

What is clobetasol propionate foam? Clobetasol propionate foam is a prescription corticosteroid medicine used in people 12 years of age and older for the treatment of: moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of the skin except the face and areas where the skin may touch or rub together. It is not known if clobetasol propionate foam is safe and effective in children under 12 years of age. clobetasol propionate foam is not recommended in children under 12 years of age.

Before using clobetasol propionate foam, tell your healthcare provider about all of your medical conditions, including if you: have had irritation or other skin reaction to a steroid medicine in the past. have a skin infection. You may need medicine to treat the skin infection before using clobetasol propionate foam. have diabetes. have adrenal gland problems. have liver problems. plan to have surgery. are pregnant or plan to become pregnant. It is not known if clobetasol propionate foam will harm your unborn baby. If you use clobetasol propionate foam during pregnancy, use clobetasol propionate foam on the smallest area of skin and for the shortest time needed. are breastfeeding or plan to breastfeed. It is not known if clobetasol propionate foam passes into your breast milk. If you use clobetasol propionate foam while breastfeeding, use clobetasol propionate foam on the smallest area of skin and for the shortest time needed. Do not apply clobetasol propionate foam directly to the nipple and areola to avoid getting clobetasol propionate foam into your baby’s mouth. Tell your healthcare provider about all the medicine you take including prescription or over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing a corticosteroid medicine during treatment with clobetasol propionate foam without talking to your healthcare provider first.

How should I use clobetasol propionate foam? See the “Instructions for Use” for detailed information about the right way to apply clobetasol propionate foam. Use clobetasol propionate foam exactly as your healthcare provider tells you to use it. Apply a thin layer of clobetasol propionate foam to the affected skin areas 2 times each day. Avoid using clobetasol propionate foam on your face, underarms (armpits), groin area, or in areas with thinning skin (atrophy). Avoid using clobetasol propionate foam on skin in a diaper area. Do not bandage or cover your treated area unless your healthcare provider tells you to. Do not use clobetasol propionate foam for longer than 2 weeks in a row. You should not use more than 50 grams or 21 capfuls of clobetasol propionate foam in 1 week. Talk to your healthcare provider if your skin or scalp does not improve after 2 weeks of treatment with clobetasol propionate foam. Wash your hands after using clobetasol propionate foam.

What should I avoid while using clobetasol propionate foam? Clobetasol propionate foam is flammable. Avoid heat, flame, or smoking during and right after you apply clobetasol propionate foam to your skin.

What are the possible side effects of clobetasol propionate foam? Clobetasol propionate foam may cause serious side effects, including: Clobetasol propionate foam can pass through your skin. Too much clobetasol propionate foam passing through your skin can cause adrenal glands to stop working. Cushing’s syndrome, a condition that happens when the body is exposed to too much of the hormone cortisol. High blood sugar (hyperglycemia) Vision problems. clobetasol propionate foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clobetasol propionate foam. Skin reactions at the treated skin site. Tell your healthcare provider if you get any skin reactions or skin infections. Effects on growth and weight in children. Your healthcare provider may do certain blood tests to check for side effects. The most common side effects of clobetasol propionate foam include burning and skin reactions at the treated site. These are not all the possible side effects of clobetasol propionate foam. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store clobetasol propionate foam? Store clobetasol propionate foam at room temperature between 68° to 77°F (20° to 25°C). Do not break through (puncture) the clobetasol propionate foam can. Never throw the can into a fire, even if the can is empty. Do not store clobetasol propionate foam near heat or store at temperatures above 120°F (49°C). Keep clobetasol propionate foam and all medicines out of the reach of children.

General information about the safe and effective use of clobetasol propionate foam. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use clobetasol propionate foam for a condition for which it was not prescribed. Do not give clobetasol propionate foam to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about clobetasol propionate foam that is written for health professionals.

What are the ingredients in clobetasol propionate foam? Active ingredient: clobetasol propionate Inactive ingredients: cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Manufactured for: Aleor Dermaceuticals Ltd., Karakhadi, Vadodara 391450, India. Manufactured by: Aleor Dermaceuticals Ltd., Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 For more information, call FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Instructions for use

Clobetasol Propionate (kloe bay’ ta sol proe’ pee oh nate)

Foam, 0.05%

Important: Clobetasol propionate foam is for use on the skin only. Do not get clobetasol propionate foam in your eyes, mouth or vagina.

How to apply clobetasol propionate foam:

Figure A	Step 1: Remove the cap and save for further use.
	Step 2: Before applying clobetasol propionate foam for the first time, break the tiny plastic piece at the base of the can’s rim by gently pushing back (away from the piece) on the nozzle. (see Figure A)
Figure B	Step 3: Turn the can upside down. Push the button to dispense a small amount of clobetasol propionate foam into the cap of the can, or on your affected skin area. (see Figure B) This amount should be no more than 1½ capfuls, about the size of a golf ball. Do not dispense clobetasol propionate foam directly onto your hands (unless your hands are the affected areas), because the foam will begin to melt right away on contact with your warm skin. If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam. If the can seems warm or the foam seems runny, run the can under cold water
Figure C Figure D	Step 4: Using your fingertips, gently massage a thin layer of clobetasol propionate foam into the affected skin areas until the foam disappears. (see Figures C and D)
Figure E	Step 5: If you are treating areas with hair, such as the scalp, move any hair away so that the foam can be applied directly to the affected areas. (see Figure E) Repeat until the affected areas are treated. Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your healthcare provider right away.
Figure F	Step 6: Wash your hands after applying clobetasol propionate foam. (see Figure F) Throw away any of the unused medicine that you dispensed out of the can.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

Manufactured by:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

Mfg. License No.: G/25/2216

Revised: 4/2022