Betamethasone Valerate (Page 3 of 3)

PATIENT INFORMATION

Betamethasone Valerate Foam
0.12% (bay″ ta meth′ a sone val′ er ate)

About Betamethasone Valerate Foam

Your doctor has prescribed betamethasone valerate foam, 0.12%, for the relief of corticosteroid-responsive skin conditions of the scalp. Betamethasone valerate foam 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 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?
Are you pregnant? Planning on becoming pregnant while using betamethasone valerate foam? Or are you breastfeeding?
Do you think you have an infection on your scalp?

How to apply betamethasone valerate foam

Application Figure 1

Turn the can upside down and dispense a small amount of betamethasone valerate foam 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.

Application Figure 2

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.

Application Figure 3

Wash your hands immediately after applying betamethasone valerate foam, and discard any unused dispensed medication.

Application Figure 4

Do not wash or rinse the treated areas immediately after applying betamethasone valerate foam.

Do not use this medication for any condition other than the one for which it was prescribed.
Betamethasone valerate foam 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:

What to do if you miss an application

If you forget to apply betamethasone valerate foam 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 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 20° to 25°C (68° to 77°F) 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 to anyone else. Your doctor has prescribed this medicine for your use only.

For additional information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215

Revised: 3/2017
PL:DPT:BETA:R1p

PRINCIPAL DISPLAY PANEL – 0.12%

NDC 0378-8180-50

Betamethasone
Valerate
Foam
0.12%

Rx only 50 g

FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.

Invert can
and then
press firmly
to dispense

Carton Label Can Inversion

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.

Dosage: See package insert for full
prescribing information. For
application to the scalp, invert can
and dispense a small amount of
betamethasone valerate foam 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 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).

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

DPT:8180:50:1C:R1

117459-0317

CFC FREE

Questions:
Call Mylan Pharmaceuticals
Inc. at 1-877-446-3679
(1-877-4-INFO-RX)

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A.

Mylan.com

Betamethasone Valerate Foam 0.12% Carton Label
(click image for full-size original)
BETAMETHASONE VALERATE betamethasone valerate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8180
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE VALERATE (BETAMETHASONE) BETAMETHASONE VALERATE 1.2 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
ALCOHOL
POLYSORBATE 60
POTASSIUM CITRATE
PROPYLENE GLYCOL
WATER
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8180-50 50 g in 1 CAN None
2 NDC:0378-8180-99 100 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020934 04/25/2017
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 03/2017 Mylan Pharmaceuticals Inc.

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