Label: CLINDACIN ETZ- clindamycin phosphate swab
CLINDACIN ETZ- clindamycin phosphate kit

  • NDC Code(s): 43538-172-60, 43538-173-60
  • Packager: Medimetriks Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 30, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    For External Use

  • DESCRIPTION

    Clindacin® ETZ contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter.

    Each Clindacin® ETZ 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, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0).

    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

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

    Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin.

    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.

    Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of clindamycin phosphate topical solution for 4 weeks was 597 mcg/g of comedonal material (range 0-1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

  • INDICATIONS AND USAGE

    Clindacin® ETZ is 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

    Clindacin® ETZ is 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

    Clindacin® ETZ 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. Clindamycin phosphate topical products 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

    Pregnancy Category B

    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 human milk following use of Clindacin® ETZ. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Use

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

    Geriatric Use

    Clinical studies for clindamycin phosphate topical solution USP, 1% 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 topical clindamycin phosphate 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
    Burning62 (11)15 (10)17 (11)
    Itching36 (7)15 (10)17 (11)
    Burning/Itching60 (11)* (-)* (-)
    Dryness105 (19)34 (23)29 (18)
    Erythema86 (16)10 (7)22 (14)
    Oiliness/Oily Skin8 (1)26 (18)12 (10)
    Peeling61 (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 Clindacin® ETZ can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

  • DOSAGE AND ADMINISTRATION

    Do not use if the unit-dose pouch seal is broken. Remove pledget just before use. Use pledget to apply a thin film of Clindamycin Phosphate Topical Solution to the affected area twice daily. More than one pledget may be used. Each pledget should be used only once and then discarded.

  • HOW SUPPLIED

    Clindacin® ETZ (Clindamycin Phosphate Topical Solution USP, 1% (Pledgets)) is available as follows:

    A carton containing 60 individually wrapped single-use pledget applicators (NDC 43538-172-60)

    STORAGE

    Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Medimetriks Pharmaceuticals, Inc.
    383 Route 46 West, Fairfield, NJ 07004-2402 • www.medimetriks.com

    Manufactured by PERRIGO
    Bronx, NY 10457

    Rev 10-16
    IP032-R3

    0T972 EK J4

  • PRINCIPAL DISPLAY PANEL - 60 Pledget Carton

    NDC 43538-172-60

    For Topical Use Only

    Rx Only

    Clindacin® ETZ
    Clindamycin Phosphate
    Topical Solution USP, 1%* (Pledgets)
    *equivalent to 1% (10 mg/mL) clindamycin

    60 Individual Pledgets

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    Principal Display Panel - 60 Pledget Carton
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC 43538-173-60

    Rx Only

    Clindacin® ETZ
    KIT

    Clindamycin Phosphate
    Topical Solution USP, 1%*
    (Pledgets)
    *equivalent to 1% (10 mg/mL) clindamycin

    CONTENTS:
    Clindacin® ETZ Clindamycin Phosphate
    Topical Solution USP, 1% (Pledgets)
    1 - Carton (60 Pledgets)

    AcuWash® Moisturizing Daily Cleanser
    1 - Bottle (16 fl. oz.)

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CLINDACIN ETZ 
    clindamycin phosphate swab
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-172
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C) clindamycin10 mg
    Inactive Ingredients
    Ingredient NameStrength
    isopropyl alcohol (UNII: ND2M416302)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-172-6060 in 1 CARTON06/15/2013
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06504906/15/2013
    CLINDACIN ETZ 
    clindamycin phosphate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-173
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-173-601 in 1 CARTON06/15/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CARTON 60 
    Part 21 BOTTLE 473 mL
    Part 1 of 2
    CLINDACIN ETZ 
    clindamycin phosphate swab
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C) clindamycin10 mg
    Inactive Ingredients
    Ingredient NameStrength
    isopropyl alcohol (UNII: ND2M416302)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06504906/15/2013
    Part 2 of 2
    ACUWASH 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRwater (UNII: 059QF0KO0R)  
    INGRcetyl alcohol (UNII: 936JST6JCN)  
    INGRlaureth-12 (UNII: OAH19558U1)  
    INGRsodium coco-sulfate (UNII: 3599J29ANH)  
    INGRsodium lauroamphoacetate (UNII: SLK428451L)  
    INGRpropylene glycol (UNII: 6DC9Q167V3)  
    INGRaloe vera leaf (UNII: ZY81Z83H0X)  
    INGRglycerin (UNII: PDC6A3C0OX)  
    INGRmagnesium aluminum silicate (UNII: 6M3P64V0NC)  
    INGRedetate disodium (UNII: 7FLD91C86K)  
    INGRxanthan gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06504906/15/2013
    Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Perrigo Inc.078846912MANUFACTURE(43538-172, 43538-173)