Varophen (Page 9 of 9)

Varophen Packaging

The packaging for Varophen is shown below:

image description
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VAROPHEN diclofenac sodium and menthol, methyl salicylate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72835-201
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72835-201-02 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 150 mL
Part 2 1 TUBE 85 g
Part 1 of 2
DICLOFENAC SODIUM diclofenac sodium solution
Product Information
Item Code (Source) NDC:60505-0399
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diclofenac Sodium (Diclofenac) Diclofenac Sodium 16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Dimethyl Sulfoxide
Glycerin
Propylene Glycol
Alcohol
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0399-5 1 BOTTLE in 1 CARTON contains a BOTTLE
1 150 mL in 1 BOTTLE This package is contained within the CARTON (60505-0399-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202027
Part 2 of 2
MUSCLE RUB menthol, methyl salicylate cream
Product Information
Item Code (Source) NDC:45802-174
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
LANOLIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
STEARIC ACID
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-174-53 1 TUBE in 1 CARTON contains a TUBE
1 85 g in 1 TUBE This package is contained within the CARTON (45802-174-53)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202027 06/03/2019
Labeler — V2 Pharma, LLC (102457346)
Establishment
Name Address ID/FEI Operations
Apotex Inc 209429182 manufacture (60505-0399)
Establishment
Name Address ID/FEI Operations
Perrigo New York Inc 078846912 label (45802-174)
Establishment
Name Address ID/FEI Operations
V2 Pharma, LLC 102457346 label (72835-201)

Revised: 12/2022 V2 Pharma, LLC

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