Clindamycin and Benzoyl Peroxide (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Clindamycin and Benzoyl Peroxide Gel, 1%/5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS

Size (Net Weight)	NDC 0781-	Benzoyl Peroxide Gel	Clindamycin Phosphate Solution (In plastic bottle)
25 grams	7263-68	20 grams	5 grams
35 grams (pump)	7275-43	28 grams	7 grams
50 grams	7287-50	40 grams	10 grams
50 grams (pump)	7291-46	40 grams	10 grams

Prior to dispensing, add the solution in the bottle to the gel and stir until homogenous in appearance (1 to 1½ minutes). For the 35 and 50 gram pumps only, reassemble jar with pump dispenser.

Clindamycin and Benzoyl Peroxide Gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.

Store at room temperature up to 25°C (77°F) [See USP].

Do not freeze. Keep tightly closed. Keep out of the reach of children.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Prescribing Information as of July 2017.

Rx Only

Manufactured by
TOLMAR Inc.
Fort Collins, CO 80526 for
Sandoz Inc. Princeton, NJ 08540

44849 Rev. 3 07/17

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50g Jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50g Pump

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25g Jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINDAMYCIN AND BENZOYL PEROXIDE clindamycin and benzoyl peroxide kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-7263

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7263-68 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 5 g Part 2 1 JAR 20 g

Part 1 of 2 CLINDAMYCIN PHOSPHATE clindamycin phosphate gel

Product Information Item Code (Source) NDC:0781-6514 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-6514-39 5 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Part 2 of 2 BENZOYL PEROXIDE benzoyl peroxide gel

Product Information Item Code (Source) NDC:0781-7262 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C LIMONENE, (+)- DOCUSATE SODIUM PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7262-22 20 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

CLINDAMYCIN AND BENZOYL PEROXIDE clindamycin and benzoyl peroxide kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-7275

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7275-43 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 7 g Part 2 1 BOTTLE, PUMP 28 g

Part 1 of 2 CLINDAMYCIN PHOSPHATE clindamycin phosphate gel

Product Information Item Code (Source) NDC:0781-6525 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-6525-17 7 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Part 2 of 2 BENZOYL PEROXIDE benzoyl peroxide gel

Product Information Item Code (Source) NDC:0781-7274 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C LIMONENE, (+)- DOCUSATE SODIUM PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7274-28 20 g in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

CLINDAMYCIN AND BENZOYL PEROXIDE clindamycin and benzoyl peroxide kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-7291

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7291-46 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 10 g Part 2 1 JAR 40 g

Part 1 of 2 CLINDAMYCIN PHOSPHATE clindamycin phosphate gel

Product Information Item Code (Source) NDC:0781-6536 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-6536-21 10 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Part 2 of 2 BENZOYL PEROXIDE benzoyl peroxide gel

Product Information Item Code (Source) NDC:0781-7290 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C LIMONENE, (+)- DOCUSATE SODIUM PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7290-48 40 g in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

CLINDAMYCIN AND BENZOYL PEROXIDE clindamycin and benzoyl peroxide kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-7287

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7287-50 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 10 g Part 2 1 BOTTLE, PUMP 40 g

Part 1 of 2 CLINDAMYCIN PHOSPHATE clindamycin phosphate gel

Product Information Item Code (Source) NDC:0781-6536 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg in 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-6536-21 10 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Part 2 of 2 BENZOYL PEROXIDE benzoyl peroxide gel

Product Information Item Code (Source) NDC:0781-7286 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg in 1 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C LIMONENE, (+)- DOCUSATE SODIUM PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0781-7286-44 40 g in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204087 08/15/2017

Labeler — Sandoz Inc. (005387188)

Establishment
Name	Address	ID/FEI	Operations
TOLMAR Inc.		791156578	ANALYSIS (0781-7287), ANALYSIS (0781-7262), ANALYSIS (0781-6525), ANALYSIS (0781-6525), ANALYSIS (0781-7274), ANALYSIS (0781-7274), ANALYSIS (0781-7290), ANALYSIS (0781-6536), ANALYSIS (0781-6536), ANALYSIS (0781-7286), ANALYSIS (0781-7275), ANALYSIS (0781-7263), ANALYSIS (0781-7291), ANALYSIS (0781-6514), LABEL (0781-7287), LABEL (0781-7262), LABEL (0781-6525), LABEL (0781-6525), LABEL (0781-7274), LABEL (0781-7274), LABEL (0781-7290), LABEL (0781-6536), LABEL (0781-6536), LABEL (0781-7286), LABEL (0781-7275), LABEL (0781-7263), LABEL (0781-7291), LABEL (0781-6514), MANUFACTURE (0781-7262), MANUFACTURE (0781-6525), MANUFACTURE (0781-6525), MANUFACTURE (0781-7274), MANUFACTURE (0781-7274), MANUFACTURE (0781-7290), MANUFACTURE (0781-6536), MANUFACTURE (0781-6536), MANUFACTURE (0781-7286), MANUFACTURE (0781-7287), MANUFACTURE (0781-7275), MANUFACTURE (0781-7263), MANUFACTURE (0781-7291), MANUFACTURE (0781-6514), PACK (0781-7262), PACK (0781-6525), PACK (0781-6525), PACK (0781-7274), PACK (0781-7274), PACK (0781-7290), PACK (0781-6536), PACK (0781-6536), PACK (0781-7286), PACK (0781-7287), PACK (0781-7275), PACK (0781-7263), PACK (0781-7291), PACK (0781-6514)

Revised: 12/2020 Sandoz Inc.