Label: NUCARARXPAK- clindamycin phosphate,benzoyl peroxide,cetaphil kit

  • NDC Code(s): 0168-0202-30, 0299-4930-02, 45802-101-96, 70859-050-01
  • Packager: NuCare Pharmaceuticals,Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 7, 2021

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

  • SPL UNCLASSIFIED SECTION

    Rx only

    For External Use.

  • DESCRIPTION

    Clindamycin Phosphate Topical Solution and Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%) contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. 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 purified water.

    The gel contains allantoin, carbomer 974P, 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:

    structural formula

    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 to 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 to 1,490). 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

    Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate 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

    Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate 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 mg 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:

    Clindamycin Phosphate 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.

    Clindamycin phosphate 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 human milk following use of clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk.

    Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Monitor the 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 breastfed child from clindamycin or from the underlying maternal condition.

    Pediatric Use:

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

    Geriatric Use:

    Clinical studies for topical Clindamycin products 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 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
    # not recorded
    * of 126 subjects

    Treatment Emergent
    Adverse Event

    Solution

    Gel

    Lotion

    n=553

    (%)

    n=148

    (%)

    n=160

    (%)

    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 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 Solution, Clindamycin Phosphate Lotion, or Clindamycin Phosphate Gel twice daily to affected area.

    Lotion: Shake well immediately before using.

    Keep all liquid dosage forms in containers tightly closed.

  • HOW SUPPLIED

    Clindamycin Phosphate Gel, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

    30 gram tube NDC 0168-0202-30

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

    Fougera

    PHARMACEUTICALS INC.

    E. FOUGERA & CO.

    A division of Fougera Pharmaceuticals Inc.

    MELVILLE, NEW YORK 11747

    46206122A/46206123A

    R03/18

  • BENZOYL PEROXIDE (45802-101-96)

  • ACTIVE INGREDIENT

    Benzoyl peroxide 2.5%

  • PURPOSE

    Acne treatmentD

  • USE

    for the treatment of acne

  • WARNINGS

    For external use only

  • DO NOT USE

    if you


    have very sensitive skin

    are sensitive to benzoyl peroxide

  • WHEN USING THIS PRODUCT

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips, and mouth
    • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
  • STOP USE AND ASK A DOCTOR IF

    • irritation becomes severe
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • DIRECTIONS

    • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily

    because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
    • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • OTHER INFORMATION

    • store at 20°-25° (68°-77°F)
  • INACTIVE INGREDIENTS

    • carbomer homopolymer, dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, sodium hydroxide
  • QUESTIONS OR COMMENTS?

    1-800-917-9260

  • ACTIVE INGREDIENTS

    Octinoxate 7.5% .................Sunscreen
    Octisalate 5% .....................Sunscreen
    Octocrylene 7% ..................Sunscreen
    Oxybenzone 6% .................Sunscreen
    Titanium Dioxide 5.7% ........Sunscreen

  • USES

    Helps prevent sunburn.

  • WARNINGS

    Skin Cancer/Skin Aging Alert:

    Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown to help prevent sunburn, not skin cancer or early aging.

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: ask a doctor.

  • INACTIVE INGREDIENTS

    Water, Propylene Glycol, Glycerin, Dimethicone, VP/Eicosene Copolymer, Cyclomethicone, Stearic Acid, Dimethiconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Aluminum Hydroxide, Disodium EDTA, Tocopherol, Triethanolamine, Phenoxyethanol, Ethylparaben, Chlorphenesin, Cetyl Alcohol, Carbomer, Methylparaben, Xanthan Gum

  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun.

  • QUESTIONS

    1-866-735-4137

  • CETAPHIL DAILY FACIAL MOISTURIZER (0299-4930-02)

  • CLINDAMYCIN PHOSPHATE GEL 30 g(0168-0202-30)

    pdp

    NDC 0168-0201-60

    Fougera ®

    CLINDAMYCIN

    PHOSPHATE

    Topical Solution USP, 1%

    Equivalent to 1%

    (10 mg/mL) clindamycin



    For Topical Use Only.

    Rx only

    60 mL

    E. FOUGERA & CO.

    A division of

    Fougera Pharmaceuticals Inc.

    Melville, New York 11747

  • BENZOYL PEROXIDE 60g (45802-101-96)

    PDP

  • CETAPHIL DAILY FACIAL MOISTURIZER 50mL (0299-4930-02)

    PDP

  • NuCaraRXPAK (70859-050-01)

    pdp

  • INGREDIENTS AND APPEARANCE
    NUCARARXPAK 
    clindamycin phosphate,benzoyl peroxide,cetaphil kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70859-050
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70859-050-011 in 1 KIT06/10/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 30 g
    Part 21 TUBE 60 g
    Part 31 TUBE 50 mL
    Part 1 of 3
    CLINDAMYCIN PHOSPHATE 
    clindamycin phosphate gel
    Product Information
    Item Code (Source)NDC:0168-0202
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0202-301 in 1 CARTON
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06416006/28/2000
    Part 2 of 3
    BENZOYL PEROXIDE 
    benzoyl peroxide gel
    Product Information
    Item Code (Source)NDC:45802-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLOXAMER 182 (UNII: JX0HIX6OAG)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-101-961 in 1 CARTON
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/13/2012
    Part 3 of 3
    CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50 
    octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide lotion
    Product Information
    Item Code (Source)NDC:0299-4930
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE57 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4930-021 in 1 CARTON
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06416001/28/2000
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300manufacture(70859-050)