Betamethasone Valerate (Page 2 of 2)

OVERDOSAGE:

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.

HOW SUPPLIED

Betamethasone Valerate
Lotion USP, 0.1%
is supplied as follows:
60ml bottles NDC 54879-004-60
Shake well before using.

Store at controlled room temperature 15° — 30°C (59° — 86°F).

To report SUSPECTED ADVERSE REACTIONS, contact STI Pharma,LLC at 1-888-301-9680 or FDA at 1-800-FDA-1088 or ww.fda.gov/medwatch

Manufactured for :
STI Pharma LLC
Newtown, PA 18940

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CONTAINER

NDC 54879-004-60

STI Pharma LLC

BETAMETHASONE VALERATE LOTION USP, 0.1%

(Potency expressed as betamethasone)

60ml

FOR DERMATOLOGIC USE ONLY

NOT OPHTHALMIC USE

Rx only

STI Pharma LLC

Container Label Front
(click image for full-size original)
Container Label Back
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 ML CARTON

NDC 54879-004-60

STI Pharma LLC

BETAMETHASONE VALERATE LOTION USP, 0.1%

(Potency expressed as betamethasone)

60ml

FOR DERMATOLOGIC USE ONLY

NOT OPHTHALMIC USE

Each gram contains 1.2 mg

betamethasone valerate (equivalent

to 1 mg betamethasone) in a vehicle

of isopropyl alcohol and water slightly

thickened with carbomer 934P.

Phosphoric acid or sodium hydroxide is used

to adjust pH.

Rx only

STI Pharma LLC

BETAMETHASONE VALERATE
betamethasone valerate lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54879-004
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE VALERATE (BETAMETHASONE) BETAMETHASONE VALERATE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL ALCOHOL
CARBOMER 934
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54879-004-60 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 60 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54879-004-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070052 07/31/1985
Labeler — STI Pharma LLC (832714070)

Revised: 01/2022 STI Pharma LLC

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