DailyMed - CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate kit

NDC Code(s): 73614-201-03, 73614-203-01, 73614-204-03, 73614-922-03
Packager: Brisk Pharmaceuticals

Category: HUMAN PRESCRIPTION DRUG LABEL

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Updated February 10, 2025

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DESCRIPTION
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 ...

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
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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 ...

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.
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INGREDIENTS AND APPEARANCE

Product Information

CLINDACARE clindamycin, ibuprofen, chlorhexidine gluconate kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:73614-922

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73614-922-03	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	02/10/2025

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

Part 1 of 4

IBUPROFEN ibuprofen tablet, film coated

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

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

Ingredient Name	Strength
Inactive Ingredients
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
Color	white	Score	no score
Shape	OVAL (CAPLET)	Size	19mm
Flavor		Imprint Code	BI8
Contains

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

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

Part 2 of 4

CHLORHEXIDINE GLUCONATE ORAL RINSE chlorhexidine gluconate oral rinse solution

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Part 3 of 4

CHLORHEXIDINE GLUCONATE ORAL RINSE chlorhexidine gluconate oral rinse solution

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Part 4 of 4

CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule

Product Information
Item Code (Source)	NDC:73614-204
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)	CLINDAMYCIN	150 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	green (LIGHT GREEN) , blue (LIGHT BLUE)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	G;143
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73614-204-03	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA216957	03/10/2023

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

Labeler - Brisk Pharmaceuticals (117250794)

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	RxCUI	RxNorm NAME	RxTTY
1	197518	clindamycin HCl 150 MG Oral Capsule	PSN
2	197518	clindamycin 150 MG Oral Capsule	SCD
3	197518	clindamycin (as clindamycin HCl) 150 MG Oral Capsule	SY
4	197807	ibuprofen 800 MG Oral Tablet	PSN
5	197807	ibuprofen 800 MG Oral Tablet	SCD
6	834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN
7	834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD
8	834127	chlorhexidine gluconate 0.12 % Mouthwash	SY
9	834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY

Label: CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate kit

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	NDC
1	73614-201-03
2	73614-203-01
3	73614-204-03
4	73614-922-03

Label: CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate kit

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CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate kit

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CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate kit

CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate kit

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CLINDACARE- clindamycin, ibuprofen, chlorhexidine gluconate kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.