Label: CLINDAMYCIN PHOSPHATE lotion

  • NDC Code(s): 21922-036-01
  • Packager: Encube Ethicals Private Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 20, 2022

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  • SPL UNCLASSIFIED SECTION
    For External Use
  • DESCRIPTION
    Clindamycin Phosphate Topical Lotion, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - The mechanism of action of clindamycin in treating acne vulgaris is unknown. Pharmacokinetics - Following multiple topical applications of clindamycin phosphate at a ...
  • INDICATIONS AND USAGE
    Clindamycin phosphate topical lotion is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should ...
  • CONTRAINDICATIONS
    Clindamycin phosphate topical lotion is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ...
  • WARNINGS
    Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of ...
  • PRECAUTIONS
    General - Clindamycin phosphate topical lotion should be prescribed with caution in atopic individuals. Drug Interactions - Clindamycin has been shown to have neuromuscular blocking properties ...
  • ADVERSE REACTIONS
    In 18 clinical studies of various formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent ...
  • OVERDOSAGE
    Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see - WARNINGS).
  • DOSAGE AND ADMINISTRATION
    Apply a thin film of clindamycin phosphate topical lotion, 1% twice daily to affected area. Shake well immediately before using. Keep all liquid dosage forms in containers tightly closed.
  • HOW SUPPLIED
    Clindamycin Phosphate Topical Lotion, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle – NDC ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for:  Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by ...
  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton Label
    NDC 21922-036-01 - Clindamycin Phosphate - Topical Lotion, 1% For topical use only - 60 mL - Rx only
  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
    NDC 21922-036-01 - Clindamycin Phosphate - Topical Lotion, 1% For topical use only - 60 mL - Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information