Rx Only

For Dermatologic Use Only

Not for Ophthalmic Use

Betamethasone valerate foam, 0.12% contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents.

Betamethasone valerate is 9-fluoro11ß,17, 21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-valerate, with the empirical formula C27H37FO6, a molecular weight of 476.58.The following is the chemical structure:

Betamethasone valerate is a white to practically white, odorless crystalline powder, and is practically insoluble in water, freely soluble in acetone and in chloroform, soluble in alcohol, and slightly soluble in benzene and in ether.

Betamethasone valerate foam, 0.12% contains 1.2 mg betamethasone valerate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid (anhydrous), ethanol (anhydrous) (60.4%), polysorbate 60, propylene glycol, purified water, stearyl alcohol, and tri-potassium citrate pressurized with a hydrocarbon (propane/butane) propellant.

Like other topical corticosteroids, betamethasone valerate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

The safety and efficacy of betamethasone valerate foam, 0.12% has been demonstrated in a four-week trial. An adequate and well-controlled clinical trial was conducted in 190 patients with moderate to severe scalp psoriasis. Patients were treated twice daily for four weeks with betamethasone valerate foam, 0.12%, Placebo foam, a commercially available betamethasone valerate lotion 0.12% (formerly expressed as 0.1% betamethasone), or Placebo lotion. At four weeks of treatment, study results of 159 patients demonstrated that the efficacy of betamethasone valerate foam, 0.12% in treating scalp psoriasis is superior to that of Placebo foam, and is comparable to that of a currently marketed BMV lotion (see Table below).

Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

Betamethasone valerate foam, 0.12% is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows:

Other adverse events which were considered to be possibly, probably, or definitely related to betamethasone valerate foam, 0.12% occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Topically applied betamethasone valerate foam, 0.12% can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS)

Note: For proper dispensing of foam, can must be inverted.

For application to the scalp invert can and dispense a small amount of betamethasone valerate foam, 0.12% onto a saucer or other cool surface. Do not dispense directly onto hands as foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of foam with fingers and gently massage into affected area until foam disappears. Repeat until entire affected scalp area is treated. Apply twice daily, once in the morning and once at night.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Betamethasone valerate foam, 0.12% should not be used with occlusive dressings unless directed by a physician.

Betamethasone valerate foam, 0.12% is supplied as follows:

• 50 g aluminum can                           NDC 70700-141-19
• 100 g aluminum can                         NDC 70700-141-20

Store at controlled room temperature 68–77°F (20–25°C).

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

Manufactured for:
Xiromed, LLC.
Florham Park, NJ 07932

Made in Spain

For additional information:
844-XIROMED (844-947-6633)

Or visit
www.xiromed.com

Revised: November 2018
PI-141-01

Betamethasone valerate foam, 0.12%

About betamethasone valerate foam, 0.12%

Your doctor has prescribed betamethasone valerate foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. Betamethasone valerate foam, 0.12% works because its active ingredient is betamethasone valerate, 0.12%. Betamethasone belongs to a group of medicines known as topical corticosteroids. These agents are used to reduce the inflammation, redness, swelling, itching, and tenderness associated with dermatologic conditions.

Other ingredients in Betamethasone Valerate Foam, 0.12% include cetyl alcohol, citric acid (anhydrous), ethanol (anhydrous) (60.4%), polysorbate 60, propylene glycol, purified water, stearyl alcohol, and tri-potassium citrate. The foam is dispensed from an aluminum can that is pressurized by a hyrdrocarbon propellant (propane and butane).

If you answer YES to one or more of the following questions, tell your doctor (or pharmacist) before using this medicine, so you can get advice about what to do. 

• Are you allergic to any of the ingredients contained in betamethasone valerate foam, 0.12%?
• Are you pregnant? Planning on becoming pregnant while using betamethasone valerate foam, 0.12%? Or are you breastfeeding?
• Do you think you have an infection on your scalp?

• Do not use this medication for any condition other than the one for which it was prescribed.
• Betamethasone valerate foam, 0.12% is for external use only.
• Keep the foam away from your eyes, as it will sting. If the foam gets into your eyes, rinse well with cold water. If the stinging continues, contact your doctor immediately.

WHAT YOU SHOULD KNOW ABOUT BETAMETHASONE VALERATE FOAM, 0.12%:

What to do if you miss an application

If you forget to apply betamethasone valerate foam, 0.12% at the scheduled time, use it as soon as you remember, and then go back to your regular schedule. If you remember at or about the time of your next daily application, apply that dose and continue with your normal application schedule. If you miss several doses, tell your doctor at your next appointment.

About side effects

As with all medications, there may be some side effects. The most frequent side effects associated with the use of betamethasone valerate foam, 0.12% include mild burning, stinging, or itching at the site of application. These side effects typically disappear shortly after application.

Let your doctor know if you notice any of the following:

• Any unusual effects that you do not understand.
• Affected areas that do not seem to be healing after several weeks of using the foam.

Important safety notes

• The treated areas should not be bandaged or covered unless directed by your doctor.
• Keep this and all medicines out of the reach of children.
• Store the can at controlled room temperature 68-77oF (20-25oC) and protect it from direct sunlight, as this is a pressurized container.
• Keep away from and do not spray near fire, open flame, or direct heat--this product is flammable. Do not smoke while using or holding the can. Keep the can away from all sources of ignition. Do not pierce or burn the can, and never throw the can in a fire, even if empty.
• When you have finished your treatment, dispose of the can safely. A completely empty can is recyclable.
• Do not use the foam after the expiration date shown on the bottom of the can.
• Do not give betamethasone valerate foam, 0.12% to anyone else. Your doctor has prescribed this medicine for your use only.

Manufactured for:
Xiromed, LLC.
Florham Park, NJ 07932 

Made in Spain

For additional information:
844-XIROMED (844-947-6633)

Or visit
www.xiromed.com

Revised: November 2018
PIL-141-01

Principal Display Panel

NDC 70700-141-19

Betamethasone Valerate Foam, 0.12%

50g

Rx Only

Principal Display Panel

NDC 70700-141-19

Betamethasone Valerate Foam, 0.12%

50g

Rx Only

Principal Display

NDC 70700-141-20

Betamethasone Valerate Foam, 0.12%

100g

Rx Only

Principal Display

NDC 70700-141-20

Betamethasone Valerate Foam, 0.12%

100g

Rx Only