NDC 0378-8134 Evoclin

Clindamycin Phosphate

NDC Product Code 0378-8134

NDC Code: 0378-8134

Proprietary Name: Evoclin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Clindamycin Phosphate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0378 - Mylan Pharmaceuticals Inc.
    • 0378-8134 - Evoclin

NDC 0378-8134-01

Package Description: 1 CAN in 1 CARTON > 100 g in 1 CAN

NDC 0378-8134-50

Package Description: 1 CAN in 1 CARTON > 50 g in 1 CAN

NDC Product Information

Evoclin with NDC 0378-8134 is a a human prescription drug product labeled by Mylan Pharmaceuticals Inc.. The generic name of Evoclin is clindamycin phosphate. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Mylan Pharmaceuticals Inc.

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Evoclin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CLINDAMYCIN PHOSPHATE 10 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALCOHOL (UNII: 3K9958V90M)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Lincosamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lincosamides - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mylan Pharmaceuticals Inc.
Labeler Code: 0378
FDA Application Number: NDA050801 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-12-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Clindamycin Topical

Clindamycin Topical is pronounced as (klin'' da mye' sin)

Why is clindamycin topical medication prescribed?
Topical clindamycin is used to treat acne. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria ...
[Read More]

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Evoclin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

EVOCLIN Foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.

2 Dosage And Administration

EVOCLIN Foam is for topical use only, and not for oral, ophthalmic, or intravaginal use.Apply EVOCLIN Foam once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area.If there has been no improvement after 6 to 8 weeks or if the condition becomes worse, treatment should be discontinued.The contents of EVOCLIN Foam are flammable; avoid fire, flame and/or smoking during and immediately following application.

3 Dosage Forms And Strengths

EVOCLIN (clindamycin phosphate) is a white to off-white thermolabile foam. EVOCLIN Foam, 1% contains 10 mg of clindamycin as clindamycin phosphate, USP per gram.

4 Contraindications

EVOCLIN Foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis).

5.1 Colitis

Systemic absorption of clindamycin has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, EVOCLIN Foam should be discontinued [see Adverse Reactions (6.2)].Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.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. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

5.2 Irritation

EVOCLIN Foam can cause irritation. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritation or dermatitis occurs, clindamycin should be discontinued. Avoid contact of EVOCLIN Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, rinse thoroughly with water.EVOCLIN Foam should be prescribed with caution in atopic individuals.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with EVOCLIN Foam.The incidence of adverse reactions occurring in ≥ 1% of the subjects in clinical trials comparing EVOCLIN Foam and its vehicle is presented in Table 1.Table 1: Adverse Reactions Occurring in ≥ 1% of SubjectsAdverse ReactionsNumber (%) of SubjectsEVOCLIN FoamVehicle FoamN = 439N = 154Headache12 (3%)1 (1%)Application site burning27 (6%)14 (9%)Application site pruritus5 (1%)5 (3%)Application site dryness4 (1%)5 (3%)Application site reaction, not otherwise specified3 (1%)4 (3%)In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to EVOCLIN Foam.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of EVOCLIN Foam: application site pain, application site erythema, diarrhea, urticaria, abdominal pain, hypersensitivity, rash, abdominal discomfort, nausea, seborrhea, application site rash, dizziness, pain of skin, colitis (including pseudomembranous colitis), and hemorrhagic diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally.

7.1 Erythromycin

EVOCLIN Foam should not be used in combination with topical or oral erythromycin-containing products due to possible antagonism to its clindamycin component. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.

7.2 Neuromuscular Blocking Agents

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

Risk Summary

There are no available data on EVOCLIN Foam use in pregnant women to inform a drug‑associated risk for adverse developmental outcomes.Animal reproduction studies have not been conducted with EVOCLIN Foam. No evidence of fetal harm or malformations was observed in pregnant rats and mice administered daily subcutaneous or oral doses of clindamycin salts during organogenesis at doses that produced exposures up to 84 and 42 times, respectively, the maximum recommended human dose (MRHD) of EVOCLIN Foam based on body surface area (BSA) comparisons and assuming 100% absorption [see Data].In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There is no information on the presence of clindamycin in human milk, or the effects on the breast-fed child, or the effects on milk production following use of EVOCLIN Foam. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EVOCLIN Foam and any potential adverse effects on the breast-fed child from EVOCLIN Foam or from the underlying maternal condition.

Animal Data

Reproduction studies have been conducted in rats and mice using subcutaneous or oral doses of clindamycin phosphate, clindamycin hydrochloride or clindamycin palmitate hydrochloride administered daily during organogenesis at doses up to the equivalent of 432 mg/kg/day clindamycin phosphate. These studies produced no evidence of fetal harm or malformations in rats or mice at exposures 84 or 42 times, respectively, the MRHD of clindamycin phosphate (i.e., 5 milliliters of EVOCLIN Foam) based on BSA comparison and assuming 100% absorption.

Clinical Considerations

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

8.4 Pediatric Use

Safety and effectiveness of EVOCLIN Foam in children under the age of 12 have not been studied.

8.5 Geriatric Use

The clinical study with EVOCLIN Foam did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

11 Description

EVOCLIN (clindamycin phosphate) Foam contains clindamycin (1%) as clindamycin phosphate.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 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). The structural formula for clindamycin phosphate is represented below:Molecular Formula: C18H34ClN2O8PS                                     Molecular Weight: 504.97 g/molEVOCLIN Foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, potassium hydroxide, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

12.1 Mechanism Of Action

Mechanism of action of clindamycin in acne vulgaris is unknown [see Microbiology (12.4)].

12.2 Pharmacodynamics

Pharmacodynamics of EVOCLIN Foam is unknown.

12.3 Pharmacokinetics

In an open label, parallel group study in 24 subjects with acne vulgaris, 12 subjects (3 male and 9 female) applied 4 grams of EVOCLIN Foam once-daily for five days, and 12 subjects (7 male and 5 female) applied 4 grams of a clindamycin gel, 1%, once daily for five days. On Day 5, the mean Cmax and AUC(0-12) were 23% and 9% lower, respectively, for EVOCLIN Foam than for the clindamycin gel, 1%.Following multiple applications of EVOCLIN Foam, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.

12.4 Microbiology

No microbiology studies were conducted in the clinical trials with this product.Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. Clindamycin has been shown to have in vitro activity against Propionibacterium acnes (P. acnes), an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical studies with EVOCLIN Foam. P. acnes resistance to clindamycin has been documented.

Inducible Clindamycin Resistance

The treatment of acne with antimicrobials is associated with the development of antimicrobial resistance in P. acnes as well as other bacteria (e.g. Staphylococcus aureus, Streptococcus pyogenes). The use of clindamycin may result in developing inducible resistance in these organisms. This resistance is not detected by routine susceptibility testing.

Cross Resistance

Resistance to clindamycin is often associated with resistance to erythromycin.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

The carcinogenicity of a 1.2% clindamycin phosphate gel similar to EVOCLIN Foam was evaluated by daily topical administration to mice for two years. The topical doses used in this study were approximately 3 and 15 times higher than the MRHD of clindamycin phosphate from EVOCLIN Foam, based on BSA comparison and assuming 100% absorption. No significant increase in tumors was noted in the treated animals.The genotoxic potential of clindamycin was evaluated in an in vitro Ames assay and in an in vivo rat micronucleus test. Both tests were negative.Reproduction studies in rats using oral doses of clindamycin hydrochloride or clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.

14 Clinical Studies

In one multicenter, randomized, double-blind, vehicle-controlled clinical trial, subjects with mild to moderate acne vulgaris used EVOCLIN Foam or the vehicle Foam once daily for twelve weeks. Treatment response, defined as the proportion of subjects clear or almost clear, based on the Investigator Static Global Assessment (ISGA), and the mean percent reductions in lesion counts at the end of treatment in this study are shown in Table 2.Table 2: Efficacy Results at Week 12Efficacy ParametersEVOCLIN FoamN = 386Vehicle FoamN = 127     Treatment response (ISGA)31%18%P < 0.05Percent reduction in lesion counts     Inflammatory Lesions49%35%     Noninflammatory Lesions38%27%     Total Lesions43%31%

16.1 How Supplied

EVOCLIN (clindamycin phosphate) Foam, 1% contains 10 mg of clindamycin as clindamycin phosphate, USP per gram. The white to off-white thermolabile foam is available as follows:NDC 0378-8134-50carton of one 50 gram aerosol canNDC 0378-8134-01carton of one 100 gram aerosol can

16.2 Storage And Handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Flammable. Avoid fire, flame or smoking during and immediately following application.Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C).Keep this and all medication out of the reach of children.

17 Patient Counseling Information

  • See FDA-Approved patient labeling (Patient Information).Instructions for Use •Patients should be advised to wash their skin with mild soap and allow it to dry before applying EVOCLIN Foam. •Patients should use enough EVOCLIN Foam to cover the face and to apply once daily. •Patients should dispense EVOCLIN Foam directly into the cap or onto a cool surface. •Patients should wash their hands after applying EVOCLIN Foam.Skin Irritation: EVOCLIN Foam may cause irritation such as erythema, scaling, itching, burning, or stinging. Patients should be advised to discontinue use if excessive irritancy or dermatitis occur.Colitis: In the event a patient treated with EVOCLIN Foam experiences severe diarrhea or gastrointestinal discomfort, EVOCLIN Foam should be discontinued and a physician should be contacted.

Patient Information

  • EVOCLIN (Ev-o-clin)(clindamycin phosphate)Foam, 1%Important Information: EVOCLIN Foam is for use on the skin only. Do not use EVOCLIN Foam in your eyes, mouth or vagina.What is EVOCLIN Foam?EVOCLIN Foam is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years and older.It is not known if EVOCLIN Foam is safe and effective in children under 12 years of age.Who should not use EVOCLIN Foam?Do not use EVOCLIN Foam if you: •have Crohn’s disease •have ulcerative colitis •have had inflammation of the colon (colitis) or severe diarrhea with past antibiotic useTell your doctor if you are not sure if you have any of the conditions listed above.What should I tell my doctor before using EVOCLIN Foam?Before using EVOCLIN Foam, tell your doctor about all of your medical conditions, including if you: •have or have had bowel problems (such as Crohn’s disease, ulcerative colitis, colitis) •have or have had eczema or other skin problems •are planning to have surgery. EVOCLIN Foam may affect how certain medicines work that may be given during surgery. •are pregnant or plan to become pregnant. It is not known if EVOCLIN Foam may harm your unborn baby. •are breastfeeding or plan to breastfeed. It is not known if EVOCLIN Foam passes into your breast milk. Talk to your doctor about using EVOCLIN Foam while breastfeeding. If you use EVOCLIN Foam while breastfeeding and EVOCLIN Foam is applied on the chest, take care to avoid getting EVOCLIN Foam into your baby’s mouth.Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. EVOCLIN Foam may affect the way other medicines work and other medicines may affect how EVOCLIN Foam works.Especially tell your doctor if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I use EVOCLIN Foam? •Use EVOCLIN Foam exactly as your doctor tells you to use it. See the detailed “Instructions for Use” for directions about how to apply EVOCLIN Foam correctly. •Wash your skin with mild soap and water and dry before applying EVOCLIN Foam. •Apply EVOCLIN Foam 1 time each day to the affected skin area. You should apply enough EVOCLIN Foam to cover the entire affected area. •Dispense EVOCLIN Foam directly into the cap. Do not dispense EVOCLIN Foam directly onto your hands or face, because the foam will begin to melt on contact with warm skin. •Wash your hands after applying EVOCLIN Foam.What should I avoid while using EVOCLIN Foam? •EVOCLIN Foam is flammable. Avoid fire, flames, or smoking during and right after you apply EVOCLIN Foam to your skin. •Avoid getting EVOCLIN Foam in or near your eyes, mouth, lips, or broken skin. If you get EVOCLIN Foam in your eyes, mouth, on lips or broken skin, rinse well with water.What are possible side effects with EVOCLIN Foam?EVOCLIN Foam may cause serious side effects, including: •Inflammation of the colon (colitis). Diarrhea, bloody diarrhea, and colitis has happened in people who use EVOCLIN Foam. Stop using EVOCLIN Foam and call your doctor right away if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and for several weeks after treatment, with EVOCLIN Foam. •Skin irritation. Stop using EVOCLIN Foam and call your doctor if you develop skin irritation during treatment with EVOCLIN Foam.The most common side effects of EVOCLIN Foam include headache and application site reactions (including burning, itching, and dryness).These are not all the possible side effects of EVOCLIN Foam. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store EVOCLIN Foam? •Store EVOCLIN Foam at room temperature between 20° to 25°C (68° to 77°F). •Keep EVOCLIN Foam away from heat. Never throw the can into a fire, even if the can is empty. •Do not store EVOCLIN Foam at temperatures above 120°F (49°C). •Do not break through (puncture) the EVOCLIN Foam can.Keep EVOCLIN Foam and all medicines out of the reach of children.General information about the safe and effective use of EVOCLIN Foam.Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use EVOCLIN Foam for a condition for which it was not prescribed. Do not give EVOCLIN Foam to other people, even if they have the same symptoms you have. It may harm them. You can also ask your pharmacist or doctor for information about EVOCLIN Foam that is written for health professionals.What are the ingredients in EVOCLIN Foam?Active ingredient: clindamycin phosphateInactive ingredients: cetyl alcohol, ethanol (58%), polysorbate 60, potassium hydroxide, propylene glycol, purified water, and stearyl alcohol. The can is pressurized with a hydrocarbon (propane/butane) propellant. Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.  Instructions for Use EVOCLIN (Ev-o-clin) (clindamycin phosphate) Foam, 1%Important Information: EVOCLIN Foam is for use on the skin only. Do not use EVOCLIN Foam in your eyes, mouth or vagina.Step 1: Remove the clear cap from the EVOCLIN Foam can. Step 2: Line up the black circle with the nozzle.Step 3: Hold the can upright and firmly press the nozzle to dispense EVOCLIN Foam into the clear cap. •Dispense enough EVOCLIN Foam to cover the entire affected area. •If the can seems warm or the foam seems runny, run the can under cold water.Step 4: Pick up small amounts of EVOCLIN Foam with your fingertips and gently rub the foam into the affected area until the foam disappears.Step 5: Wash your hands after applying EVOCLIN Foam. •Throw away any of the unused medicine that you dispensed out of the can.How should I store EVOCLIN Foam? •Store EVOCLIN Foam at room temperature between 20° to 25°C (68° to 77°F). •Keep EVOCLIN Foam away from heat. Never throw the can into a fire, even if the can is empty. •Do not store EVOCLIN Foam at temperatures above 120°F (49°C). •Do not break through (puncture) the EVOCLIN Foam can.Keep EVOCLIN Foam and all medicines out of the reach of children.The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. EVOCLIN is a registered trademark of Stiefel Laboratories, Inc., a GSK Company, exclusively licensed to the Mylan Companies.©2018 Delcor Asset Corporation, a Mylan CompanyManufactured for:Mylan Pharmaceuticals Inc.Morgantown, WV 26505 U.S.A.Manufactured by:DPT Laboratories, Ltd.San Antonio, TX 78215 U.S.A.Revised: 4/2018140944-0418DPT:CLINPHFO:R2

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