CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% : 45 grams

Container Label-

NDC 21922- 022 -06
Clindamycin Phosphate and

Benzoyl Peroxide Gel, 1.2%/5%
FOR EXTERNAL USE ONLY

45 grams

R X ONLY

cl
(click image for full-size original)

Carton Label-

NDC 21922- 022 -06
Clindamycin Phosphate and

Benzoyl Peroxide Gel, 1.2%/5% FOR EXTERNAL USE ONLY

45 grams

R X ONLY

cc
(click image for full-size original)

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE clindamycin phosphate and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21922-022
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
CARBOMER HOMOPOLYMER TYPE C
EDETATE DISODIUM
DIMETHICONE
GLYCERIN
SILICON DIOXIDE
POLOXAMER 182
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21922-022-06 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (21922-022-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212433 05/20/2021
Labeler — Encube Ethicals Private Limited (915834105)
Registrant — Encube Ethicals Private Limited (915834105)
Establishment
Name Address ID/FEI Operations
Encube Ethicals Private Limited 725076298 manufacture (21922-022), analysis (21922-022), pack (21922-022), label (21922-022)

Revised: 05/2021 Encube Ethicals Private Limited

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.