Label: CLEOCIN T- clindamycin phosphate solution
CLEOCIN T- clindamycin phosphate lotion
CLEOCIN T- clindamycin phosphate gel

  • NDC Code(s): 0009-3116-01, 0009-3116-02, 0009-3116-14, 0009-3329-01, view more
    0009-3331-01, 0009-3331-02
  • Packager: Pharmacia & Upjohn Company LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 26, 2023

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  • SPL UNCLASSIFIED SECTION

    For External Use

  • DESCRIPTION

    CLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each CLEOCIN T Topical Solution pledget applicator contains approximately 1 mL of topical solution.

    Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

    The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water.

    The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

    The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water.

    The structural formula is represented below:

    Chemical Structure

    The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).

  • 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 concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

    Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

    Microbiology

    Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

    Antimicrobial Activity

    Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.

    Resistance

    Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.

  • INDICATIONS AND USAGE

    CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).

  • CONTRAINDICATIONS

    CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

  • 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 the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

    Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

    When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.

    Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.

    Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

  • PRECAUTIONS

    General

    CLEOCIN T Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.

    CLEOCIN T should be prescribed with caution in atopic individuals.

    Drug Interactions

    Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

    Pregnancy

    Teratogenic effects

    In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

    Nursing Mothers

    It is not known whether clindamycin is excreted in breast milk following use of CLEOCIN T. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.

    The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition.

    Clinical Considerations

    If used during lactation and CLEOCIN T is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

    Pediatric Use

    Safety and effectiveness in pediatric patients under the age of 12 have not been established.

    Geriatric Use

    Clinical studies for CLEOCIN T did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

  • ADVERSE REACTIONS

    In 18 clinical studies of various formulations of CLEOCIN T using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].

    Number of Patients Reporting Events
    Treatment Emergent
    Adverse Event
    Solution
    n=553(%)
    Gel
    n=148(%)
    Lotion
    n=160(%)
    # not recorded
    *
    of 126 subjects

    Burning

    62 (11)

    15 (10)

    17 (11)

    Itching

    36 ( 7)

    15 (10)

    17 (11)

    Burning/Itching

    60 (11)

    # ( – )

    # ( – )

    Dryness

    105 (19)

    34 (23)

    29 (18)

    Erythema

    86 (16)

    10 ( 7)

    22 (14)

    Oiliness/Oily Skin

    8 ( 1)

    26 (18)

    12* (10)

    Peeling

    61 (11)

    # ( – )

    11 ( 7)

    Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.

    Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS).

    Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

  • OVERDOSAGE

    Topically applied CLEOCIN T can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

  • DOSAGE AND ADMINISTRATION

    Apply a thin film of CLEOCIN T Topical Solution, CLEOCIN T Topical Lotion, CLEOCIN T Topical Gel, or use a CLEOCIN T Topical Solution pledget for the application of CLEOCIN T twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded.

    Lotion: Shake well immediately before using.

    Pledget: Remove pledget from foil just before use. Do not use if the seal is broken. Discard after single use.

    Keep all liquid dosage forms in containers tightly closed.

  • HOW SUPPLIED

    CLEOCIN T Topical Solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:

    30 mL applicator bottle—NDC 0009-3116-01

    60 mL applicator bottle—NDC 0009-3116-02

    Carton of 60 single-use pledget applicators—NDC 0009-3116-14

    CLEOCIN T Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

    60 gram tube—NDC 0009-3331-01

    30 gram tube—NDC 0009-3331-02

    CLEOCIN T Topical Lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size:

    60 mL plastic squeeze bottle—NDC 0009-3329-01

    Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

    Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Rx only

    This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

    Logo

    LAB-0042-10.0
    Revised 12/2019

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    Pfizer

    NDC 0009-3116-01

    Cleocin T®
    clindamycin phosphate
    topical solution, USP

    1%*

    Solution for topical use only

    30 mL

    Rx only

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    Pfizer

    NDC 0009-3116-01

    Cleocin T®
    clindamycin
    phosphate
    topical solution,
    USP

    1%*

    Solution for topical
    use only

    30 mL
    Rx only

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • PRINCIPAL DISPLAY PANEL - Pledget Packet

    Pfizer

    NDC 0009-3116-14

    Cleocin T®
    clindamycin phosphate
    topical solution, USP

    1%*

    Pledget for topical use only

    1 Pledget

    Distributed by
    Pharmacia & Upjohn Co
    Division of Pfizer Inc, NY, NY 10017
    MADE IN CHINA

    Rx only

    PRINCIPAL DISPLAY PANEL - Pledget Packet
  • PRINCIPAL DISPLAY PANEL - 60 Pledget Packet Carton

    NDC 0009-3116-14

    Pfizer
    Cleocin T®
    1%*
    clindamycin phosphate
    topical solution, USP

    Pledget for topical use only

    60 Pledgets
    Rx only

    PRINCIPAL DISPLAY PANEL - 60 Pledget Packet Carton
  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    Pfizer
    NDC 0009-3329-01

    Cleocin T®
    clindamycin
    phosphate
    topical lotion

    1%*

    For topical use only

    60 mL
    Rx only

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    Pfizer
    NDC 0009-3329-01

    Cleocin T®
    clindamycin
    phosphate
    topical lotion

    1%*

    For topical use only

    60 mL
    Rx only

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 60 gram Tube Label

    NDC 0009-3331-01

    60 gram

    Rx only

    Cleocin T®
    clindamycin phosphate topical gel

    For topical use only

    1%*

    Store at controlled room temperature 20° to 25°C (68° to 77°F)
    [see USP]. Protect from freezing.
    For external use only. Avoid contact with eyes.
    See crimp of tube for Expiration Date and Lot Number.
    DOSAGE AND USE: See accompanying prescribing information.
    * Each gram contains clindamycin phosphate equivalent to 10 mg
    (1%) of clindamycin. Also contains allantoin, carbomer 934P,
    methylparaben, polyethylene glycol 400, propylene glycol, sodium
    hydroxide, and purified water.

    Pfizer
    Distributed by
    Pharmacia & Upjohn Co
    Division of Pfizer Inc, NY, NY 10017

    PRINCIPAL DISPLAY PANEL - 60 gram Tube Label
  • PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton

    NDC 0009-3331-01

    Pfizer

    Cleocin T®
    1%*

    clindamycin phosphate topical gel

    For topical use only

    60 gram
    Rx only

    PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30 gram Tube Label

    NDC 0009-3331-02

    30 gram

    Rx only

    Cleocin T®
    clindamycin phosphate topical gel

    For topical use only

    1%*

    Store at controlled room temperature 20° to 25°C (68° to 77°F)
    [see USP]. Protect from freezing.
    For external use only. Avoid contact with eyes.
    See crimp of tube for Expiration Date and Lot Number.
    DOSAGE AND USE: See accompanying prescribing information.
    * Each gram contains clindamycin phosphate equivalent to 10 mg
    (1%) of clindamycin. Also contains allantoin, carbomer 934P,
    methylparaben, polyethylene glycol 400, propylene glycol, sodium
    hydroxide, and purified water.

    Pfizer
    Distributed by
    Pharmacia & Upjohn Co
    Division of Pfizer Inc, NY, NY 10017

    PRINCIPAL DISPLAY PANEL - 30 gram Tube Label
  • PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

    NDC 0009-3331-02

    Pfizer
    Cleocin T®
    1%*
    clindamycin phosphate topical gel

    For topical use only

    30 gram
    Rx only

    PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLEOCIN T 
    clindamycin phosphate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-3116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-3116-011 in 1 CARTON06/20/198003/31/2018
    130 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0009-3116-021 in 1 CARTON06/20/198006/30/2018
    260 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3NDC:0009-3116-1460 in 1 CARTON06/20/198003/31/2019
    31 mL in 1 PACKET; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05053706/20/198003/31/2019
    CLEOCIN T 
    clindamycin phosphate lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-3329
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-3329-011 in 1 CARTON05/31/1989
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05060005/31/1989
    CLEOCIN T 
    clindamycin phosphate gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0009-3331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0009-3331-011 in 1 CARTON01/07/198710/31/2021
    160 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0009-3331-021 in 1 CARTON01/07/198710/31/2021
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05061501/07/198710/31/2021
    Labeler - Pharmacia & Upjohn Company LLC (618054084)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia & Upjohn Company LLC618054084ANALYSIS(0009-3116, 0009-3329, 0009-3331) , MANUFACTURE(0009-3116, 0009-3329, 0009-3331) , API MANUFACTURE(0009-3116) , PACK(0009-3116, 0009-3329, 0009-3331) , LABEL(0009-3116, 0009-3329, 0009-3331)