Clindamycin and Benzoyl Peroxide (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Clindamycin and Benzoyl Peroxide Gel 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 Number

Benzoyl Peroxide Gel

Active Clindamycin powder (In plastic vial)

Purified Water To Be Added to each vial

25 grams

68462-486-19

19.7g

0.3g

5 mL

35 grams

68462-486-24

27.6g

0.4g

7 mL

35 grams (pump)

68462-859-24

27.6g

0.4g

7 mL

50 grams

68462-486-27

39.4g

0.6g

10 mL

50 grams (pump)

68462-859-27

39.4g

0.6g

10 mL

Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark. Add the solution in the vial 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 (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 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

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

Rx Only

Manufactured by:
Glenmark Pharmaceuticals Limited

Colvale-Bardez, Goa 403513, India

Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

August 2021

Label Display Panel – 25 gram Kit Carton

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Label Display Panel — 35 gram Kit Carton

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Label Display Panel – 50 gram Kit Carton

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PRINCIPAL DISPLAY PANEL – 35 g Pump Pack

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PRINCIPAL DISPLAY PANEL – 50 g Pump Pack

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CLINDAMYCIN AND BENZOYL PEROXIDE
clindamycin and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-486
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN PHOSPHATE 10 mg in 1 g
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM
EDETATE DISODIUM
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-486-19 1 JAR in 1 CARTON contains a JAR
1 25 g in 1 JAR This package is contained within the CARTON (68462-486-19)
2 NDC:68462-486-24 1 JAR in 1 CARTON contains a JAR
2 35 g in 1 JAR This package is contained within the CARTON (68462-486-24)
3 NDC:68462-486-27 1 JAR in 1 CARTON contains a JAR
3 50 g in 1 JAR This package is contained within the CARTON (68462-486-27)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209252 03/14/2019
CLINDAMYCIN AND BENZOYL PEROXIDE
clindamycin and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-859
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN PHOSPHATE 10 mg in 1 g
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM
EDETATE DISODIUM
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-859-24 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 35 g in 1 BOTTLE, PUMP This package is contained within the CARTON (68462-859-24)
2 NDC:68462-859-27 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
2 50 g in 1 BOTTLE, PUMP This package is contained within the CARTON (68462-859-27)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209252 09/24/2021
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE (68462-486), MANUFACTURE (68462-859), ANALYSIS (68462-486), ANALYSIS (68462-859)

Revised: 08/2021 Glenmark Pharmaceuticals Inc., USA

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