Calcipotriene and Betamethasone Dipropionate: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 60 g Tube Carton

NDC 66993-938-61
Rx only

PRASCO

Calcipotriene 0.005% and
Betamethasone Dipropionate 0.064%
Ointment

For Topical Use OnlyNet Wt. 60 g

PRINCIPAL DISPLAY PANEL -- 60 g Tube Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 g Tube Carton

NDC 66993-938-65
Rx only

PRASCO

Calcipotriene 0.005% and
Betamethasone Dipropionate 0.064%
Ointment

For Topical Use OnlyNet Wt. 100 g

PRINCIPAL DISPLAY PANEL -- 100 g Tube Carton
(click image for full-size original)
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE calcipotriene and betamethasone dipropionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-938
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIPOTRIENE MONOHYDRATE (CALCIPOTRIENE) CALCIPOTRIENE 50 ug in 1 g
BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL, DL-
MINERAL OIL
PETROLATUM
POLYPROPYLENE GLYCOL 11 STEARYL ETHER
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-938-61 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (66993-938-61)
2 NDC:66993-938-65 1 TUBE in 1 CARTON contains a TUBE
2 100 g in 1 TUBE This package is contained within the CARTON (66993-938-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021852 01/28/2020
Labeler — Prasco Laboratories (065969375)
Registrant — LEO Pharma Inc. (832692615)
Establishment
Name Address ID/FEI Operations
LEO Laboratories Ltd. 219532322 ANALYSIS (66993-938), MANUFACTURE (66993-938), PACK (66993-938), LABEL (66993-938)

Revised: 12/2022 Prasco Laboratories

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