SALLUS Pain Relief Collection with Naproxen (Page 6 of 6)

Packaging

Sallus
(click image for full-size original)

Established Pharmacological Class
Substance Pharmacological Class
SALLUS COMFORT GEL Other Skin Care Preparations
SALLUS PAIN RELIEF COLLECTION WITH NAPROXEN naproxen kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69036-221
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69036-221-15 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30
Part 2 1 BOTTLE, PLASTIC 60 mL
Part 1 of 2
NAPROXEN naproxen tablet
Product Information
Item Code (Source) NDC:69036-220(NDC:68462-190)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
POVIDONES
MAGNESIUM STEARATE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color orange (Light orange) Score 2 pieces
Shape CAPSULE Size 16mm
Flavor Imprint Code G;32;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69036-220-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078250 07/01/2007
Part 2 of 2
SALLUS COMFORT GEL
Product Information
Ingredients
Ingredient Name Quantity
METHYL SALICYLATE
MENTHOL, UNSPECIFIED FORM
CAPSICUM OLEORESIN
CETOSTEARYL ALCOHOL
CETYL ESTERS WAX
GLYCERYL MONOSTEARATE
POLYOXYL 20 CETOSTEARYL ETHER
CASTOR OIL
PROPYLPARABEN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078250 07/01/2007
Labeler — Sallus Laboratories, Llc (079418254)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 manufacture (69036-220)
Establishment
Name Address ID/FEI Operations
Integrated Pharma Solutions LLC 049528220 repack (69036-221)

Revised: 02/2016 Sallus Laboratories, Llc

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