Betamethasone valerate BETAMETHASONE VALERATE ALEMBIC PHARMACEUTICALS LIMITED FDA Approved Betamethasone valerate foam, 0.12% contains betamethasone valerate, 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 9α-fluoro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione-17-valerate, with the empirical formula C 27 H 37 FO 6 , a molecular weight of 476.58. The following is the chemical structure: Betamethasone valerate Betamethasone valerate, USP is a white to almost-white, 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, ethanol (60.4%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Image
FunFoxMeds bottle
Route
TOPICAL
Applications
ANDA215832

Drug Facts

Composition & Profile

Strengths
0.12 % 1.2 mg 50 g 100 g
Treats Conditions
Indications And Usage 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

Identifiers & Packaging

Container Type BOTTLE
UPC
0346708708504
UNII
9IFA5XM7R2
Packaging

HOW SUPPLIED Betamethasone valerate foam, 0.12% contains 1.2 mg of betamethasone valerate, USP per gram. It is white to off white foam available as follows: NDC 46708-708-50 carton containing one 50 g aluminum can NDC 46708-708-31 carton containing one 100 g aluminum can 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]. WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep this and all medication out of the 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 by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 PATIENT INFORMATION Betamethasone Valerate (bay'' ta meth' a sone val' er ate) 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, ethanol, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by a hydrocarbon 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? How to apply betamethasone valerate foam, 0.12% Turn the can upside down and dispense a small amount of betamethasone valerate foam, 0.12% onto a clean saucer or other cool, clean 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. Use sparingly—only enough to cover the affected areas. Gently massage the foam in until it is absorbed and allow the areas to dry naturally. When applying to the scalp, move the hair away so that the foam can be applied directly to each affected area. Wash your hands immediately after applying betamethasone valerate foam, 0.12%, and discard any unused dispensed medication. Do not wash or rinse the treated areas immediately after applying betamethasone valerate foam, 0.12%. 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 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] 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. For additional information visit www.alembicusa.com Questions: Call at 1-866-210-9797. Side effects should be reported to this number. Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 09/2025 Image Image Image Image; PRINCIPAL DISPLAY PANEL NDC 46708-708-50 Betamethasone Valerate Foam, 0.12% Rx only 50 grams FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Invert can and then press firmly to dispense. Description: 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, ethanol (60.4%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Usual Dosage: See accompanying prescribing information. 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. WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep away from eyes or other mucous membranes. Keep this and all medication out of the 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). 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]. CFC FREE Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Questions: Call at 1-866-210-9797. Side effects should be reported to this number. NDC 46708-708-50 Betamethasone Valerate Foam, 0.12% Rx only 50 grams FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. 50 g can 50 g carton Image

Package Descriptions
  • HOW SUPPLIED Betamethasone valerate foam, 0.12% contains 1.2 mg of betamethasone valerate, USP per gram. It is white to off white foam available as follows: NDC 46708-708-50 carton containing one 50 g aluminum can NDC 46708-708-31 carton containing one 100 g aluminum can 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]. WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep this and all medication out of the 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 by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 PATIENT INFORMATION Betamethasone Valerate (bay'' ta meth' a sone val' er ate) 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, ethanol, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol. The foam is dispensed from an aluminum can that is pressurized by a hydrocarbon 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? How to apply betamethasone valerate foam, 0.12% Turn the can upside down and dispense a small amount of betamethasone valerate foam, 0.12% onto a clean saucer or other cool, clean 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. Use sparingly—only enough to cover the affected areas. Gently massage the foam in until it is absorbed and allow the areas to dry naturally. When applying to the scalp, move the hair away so that the foam can be applied directly to each affected area. Wash your hands immediately after applying betamethasone valerate foam, 0.12%, and discard any unused dispensed medication. Do not wash or rinse the treated areas immediately after applying betamethasone valerate foam, 0.12%. 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 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] 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. For additional information visit www.alembicusa.com Questions: Call at 1-866-210-9797. Side effects should be reported to this number. Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 09/2025 Image Image Image Image
  • PRINCIPAL DISPLAY PANEL NDC 46708-708-50 Betamethasone Valerate Foam, 0.12% Rx only 50 grams FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Invert can and then press firmly to dispense. Description: 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, ethanol (60.4%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Usual Dosage: See accompanying prescribing information. 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. WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep away from eyes or other mucous membranes. Keep this and all medication out of the 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). 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]. CFC FREE Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Questions: Call at 1-866-210-9797. Side effects should be reported to this number. NDC 46708-708-50 Betamethasone Valerate Foam, 0.12% Rx only 50 grams FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. 50 g can 50 g carton Image

Overview

Betamethasone valerate foam, 0.12% contains betamethasone valerate, 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 9α-fluoro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione-17-valerate, with the empirical formula C 27 H 37 FO 6 , a molecular weight of 476.58. The following is the chemical structure: Betamethasone valerate Betamethasone valerate, USP is a white to almost-white, 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, ethanol (60.4%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Image

Indications & Usage

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.

Dosage & Administration

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.

Warnings & Precautions
No warnings available yet.
Contraindications

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.

Adverse Reactions

The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows: Incidence and severity of burning/itching/stinging Product Total incidence Maximum severity Mild Moderate Severe Betamethasone Valerate Foam n = 63 34 (54%) 28 (44%) 5 (8%) 1 (2%) Betamethasone Valerate Lotion n = 63 33 (52%) 26 (41%) 6 (10%) 1 (2%) Placebo Foam n = 32 24 (75%) 13 (41%) 7 (22%) 4 (12%) Placebo Lotion n=30 20 (67%) 12 (40%) 5 (17%) 3 (10%) Other adverse events which were considered to be possibly, probably, or definitely related to betamethasone valerate foam 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.


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