Label: CLINDAMYCIN PHOSPHATE solution

  • NDC Code(s): 70771-1414-2, 70771-1414-3
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1414-2

    Clindamycin phosphate topical solution USP, 1%

    Rx only

    Clindamycin phosphate topical solution USP, 1.0%
    Clindamycin phosphate topical solution USP, 1.0%
  • INGREDIENTS AND APPEARANCE
    CLINDAMYCIN PHOSPHATE 
    clindamycin phosphate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1414-21 in 1 CARTON01/03/2019
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70771-1414-31 in 1 CARTON01/03/2019
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20876701/03/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (650650802)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1414) , MANUFACTURE(70771-1414)