Wynzora (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 60 g Tube Carton

Wynzora®
(calcipotriene and betamethasone dipropionate)
Cream, 0.005%/0.064%

NDC 73499-001-01

Rx only
Net Wt. 60 g

For Topical Use OnlyNot for ophthalmic, oral or intravaginal use

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

PRINCIPAL DISPLAY PANEL — 5 g Tube Carton

NDC 73499-001-03

Wynzora®
(calcipotriene and betamethasone dipropionate)
Cream, 0.005%/0.064%

Net Wt. 10 x 5 g

Samples – Not for sale

For Topical Use OnlyNot for ophthalmic, oral or intravaginal use

PRINCIPAL DISPLAY PANEL -- 5 g Tube Carton
(click image for full-size original)
WYNZORA calcipotriene and betamethasone dipropionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73499-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcipotriene (Calcipotriene) Calcipotriene 50 ug in 1 g
Betamethasone dipropionate (Betamethasone) Betamethasone 64 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isopropyl myristate
Mineral oil
Medium-chain triglycerides
Isopropyl alcohol
Laureth-4
Poloxamer 407
Polyoxyl 40 hydrogenated castor oil
Carbomer interpolymer type A (Allyl Sucrose Crosslinked)
Butylated hydroxyanisole
Trolamine
Sodium phosphate, dibasic, heptahydrate
Sodium phosphate, monobasic, monohydrate
.Alpha.-Tocopherol, Dl-
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73499-001-01 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (73499-001-01)
2 NDC:73499-001-03 10 TUBE in 1 CARTON contains a TUBE
2 5 g in 1 TUBE This package is contained within the CARTON (73499-001-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213422 06/30/2021
Labeler — MC2 Therapeutics Ltd (345388560)

Revised: 06/2021 MC2 Therapeutics Ltd

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