CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate 
Brisk Pharmaceuticals

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.

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ClindaCare

Rx Only

NDC 73614-922-03

ClindaCare™

Each Pack Contains:

Clindamycin Hydrochloride Capsules, USP 150 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

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.

box

clindamycin

ibu

chlorhex

CLINDACARE 
clindamycin, ibuprofen, chlorhexidine gluconate kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73614-922
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73614-922-031 in 1 CARTON; Type 1: Convenience Kit of Co-Package02/10/2025
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 
Part 21 BOTTLE 118 mL
Part 31 BOTTLE 118 mL
Part 41 BOTTLE 30 
Part 1 of 4
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Item Code (Source)NDC:73614-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 mg
Inactive Ingredients
Ingredient NameStrength
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)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (CAPLET) Size19mm
FlavorImprint Code BI8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73614-201-0330 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20241305/23/2024
Part 2 of 4
CHLORHEXIDINE GLUCONATE ORAL RINSE 
chlorhexidine gluconate oral rinse solution
Product Information
Item Code (Source)NDC:73614-203
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE1.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73614-203-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07556107/27/2023
Part 3 of 4
CHLORHEXIDINE GLUCONATE ORAL RINSE 
chlorhexidine gluconate oral rinse solution
Product Information
Item Code (Source)NDC:73614-203
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE1.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73614-203-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07556107/27/2023
Part 4 of 4
CLINDAMYCIN HYDROCHLORIDE 
clindamycin hydrochloride capsule
Product Information
Item Code (Source)NDC:73614-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN150 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
Colorgreen (LIGHT GREEN) , blue (LIGHT BLUE) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code G;143
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73614-204-0330 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21695703/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/10/2025
Labeler - Brisk Pharmaceuticals (117250794)

Revised: 2/2025
Document Id: 2df8a89c-38e0-c63b-e063-6394a90aaa36
Set id: 2df8a89c-38df-c63b-e063-6394a90aaa36
Version: 1
Effective Time: 20250210
 
Brisk Pharmaceuticals