Label: ORAPAZ- cephalexin, ibuprofen, chlorhexidine gluconate kit
- NDC Code(s): 73614-201-03, 73614-202-03, 73614-203-01, 73614-417-03
- Packager: Brisk Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 11, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DESCRIPTION
-
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
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INGREDIENTS AND APPEARANCE
ORAPAZ
cephalexin, ibuprofen, chlorhexidine gluconate kitProduct 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 solutionProduct 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 capsuleProduct 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 coatedProduct 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 solutionProduct 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)
