ORAPAZ- cephalexin, ibuprofen, chlorhexidine gluconate kit

Orapaz by

Drug Labeling and Warnings

Orapaz by is a Prescription medication manufactured, distributed, or labeled by Brisk Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Rx Only

NDC: 73614-417-03

ORAPAZ™
Each Pack Contains:
Cephalexin Capsules, USP 500 mg - One 30 ct Bottle
Ibuprofen Tablets, USP 800 mg - One 30 ct Bottle
Chlorhexidine Gluconate Oral Rinse, USP 0.12% - Two 118 ml Bottles

Brisk Pharmaceuticals

DESCRIPTION

Packaged by:

Unit Dose Solutions Inc.,

Morrisville, NC 27560

Distributed by:

Brisk pharmaceuticals,

Richardson, TX 75081

Keep out of reach of children.

Storage: Store at 20°C to 25°C

(68°F-77°F).

Lot: See the lot number on each

individual bottle inside the pack.

Exp: See the expiration date on each

individual bottle inside the pack.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAPAZ 
cephalexin, ibuprofen, chlorhexidine gluconate kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 73614-417

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73614-417-03	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	02/10/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE	30
Part 3	1 BOTTLE	30
Part 4	1 BOTTLE	118 mL

Part 1 of 4

CHLORHEXIDINE GLUCONATE ORAL RINSE 
chlorhexidine gluconate oral rinse solution

Product Information
Item Code (Source)	NDC: 73614-203
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73614-203-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075561	07/27/2023

Part 2 of 4

CEPHALEXIN 
cephalexin capsule

Product Information
Item Code (Source)	NDC: 73614-202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)	CEPHALEXIN ANHYDROUS	500 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	green (Dark Green Opaque, Light Green Opaque)	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	A;43;500;mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73614-202-03	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065253	11/16/2005

Part 3 of 4

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Item Code (Source)	NDC: 73614-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	800 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (CAPLET)	Size	19mm
Flavor		Imprint Code	BI8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73614-201-03	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202413	05/23/2024

Part 4 of 4

CHLORHEXIDINE GLUCONATE ORAL RINSE 
chlorhexidine gluconate oral rinse solution

Product Information
Item Code (Source)	NDC: 73614-203
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73614-203-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075561	07/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/10/2025

Labeler - Brisk Pharmaceuticals (117250794)