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 SECTIONFor External Use
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DESCRIPTIONClindamycin 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 ...
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CLINICAL PHARMACOLOGYMechanism of Action - The mechanism of action of clindamycin in treating acne vulgaris is unknown. Pharmacokinetics - Following multiple topical applications of clindamycin phosphate at a ...
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INDICATIONS AND USAGEClindamycin 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 ...
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CONTRAINDICATIONSClindamycin phosphate topical lotion is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ...
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WARNINGSOrally 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 ...
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PRECAUTIONSGeneral - Clindamycin phosphate topical lotion should be prescribed with caution in atopic individuals. Drug Interactions - Clindamycin has been shown to have neuromuscular blocking properties ...
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ADVERSE REACTIONSIn 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 ...
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OVERDOSAGETopically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see - WARNINGS).
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DOSAGE AND ADMINISTRATIONApply 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.
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HOW SUPPLIEDClindamycin 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 ...
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SPL UNCLASSIFIED SECTIONManufactured for: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by ...
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PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton LabelNDC 21922-036-01 - Clindamycin Phosphate - Topical Lotion, 1% For topical use only - 60 mL - Rx only
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PRINCIPAL DISPLAY PANEL - 60 mL Bottle LabelNDC 21922-036-01 - Clindamycin Phosphate - Topical Lotion, 1% For topical use only - 60 mL - Rx only
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INGREDIENTS AND APPEARANCEProduct Information