NDC 0009-3329 Cleocin T
Clindamycin Phosphate Lotion Topical

Product Information

What is NDC 0009-3329?

The NDC code 0009-3329 is assigned by the FDA to the product Cleocin T which is a human prescription drug product labeled by Pharmacia & Upjohn Company Llc. The generic name of Cleocin T is clindamycin phosphate. The product's dosage form is lotion and is administered via topical form. The product is distributed in a single package with assigned NDC code 0009-3329-01 1 bottle in 1 carton / 60 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0009-3329
Proprietary Name 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.
Cleocin T
Non-Proprietary Name 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.
Clindamycin Phosphate
Product Type 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.
Human Prescription Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Pharmacia & Upjohn Company Llc
Labeler Code0009
FDA Application Number 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.
NDA050600
Marketing Category 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.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-31-1989
Listing Expiration Date 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.
12-31-2024
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Cleocin T?


Product Packages

NDC Code 0009-3329-01

Package Description: 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

Price per Unit: $0.46517 per ML

Product Details

What are Cleocin T Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Cleocin T Active Ingredients UNII Codes

Cleocin T Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

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]

* Please review the disclaimer below.

Cleocin T Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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:

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).


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.


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.


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
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

of 126 subjects

(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 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


Storage And Handling



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

Protect from freezing.


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 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 - 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 - 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 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 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 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 Carton



NDC 0009-3331-01

Pfizer

Cleocin T®
1%*

clindamycin phosphate topical gel

For topical use only

60 gram
Rx only


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 Carton



NDC 0009-3331-02

Pfizer
Cleocin T®
1%*
clindamycin phosphate topical gel

For topical use only

30 gram
Rx only


* Please review the disclaimer below.