Clindamycin Phoaphate Topical Solution Usp, 1%

Clindamycin Phosphate Topical Solution Usp, 1%

Encube Ethicals Private Limited
Human Prescription Drug
NDC 21922-002

Clindamycin Phoaphate Topical Solution Usp, 1% also known as Clindamycin Phosphate Topical Solution Usp, 1% is a human prescription drug labeled by 'Encube Ethicals Private Limited'. National Drug Code (NDC) number for Clindamycin Phoaphate Topical Solution Usp, 1% is 21922-002. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Clindamycin Phoaphate Topical Solution Usp, 1% drug includes Clindamycin Phosphate - 10 mg/mL . The currest status of Clindamycin Phoaphate Topical Solution Usp, 1% drug is Active.

Drug Information:

Drug NDC:	21922-002
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Clindamycin Phoaphate Topical Solution Usp, 1%
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Clindamycin Phosphate Topical Solution Usp, 1%
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Encube Ethicals Private Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CLINDAMYCIN PHOSPHATE - 10 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	04 Mar, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA209914
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Encube Ethicals Private Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	309333
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0321922002218 0321922002010
UPC stands for Universal Product Code.
UNII:	EH6D7113I8
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Decreased Sebaceous Gland Activity [PE] Lincosamide Antibacterial [EPC] Lincosamides [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
21922-002-01	1 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLE	04 Mar, 2019	N/A	No
21922-002-21	1 BOTTLE in 1 CARTON (21922-002-21) / 30 mL in 1 BOTTLE	13 Jul, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Clindamycin Phoaphate Topical Solution Usp, 1%

Clindamycin Phosphate Topical Solution Usp, 1%

Solution
Encube Ethicals Private Limited
NDC: 21922-002

Product Elements:

Clindamycin phoaphate topical solution usp, 1% clindamycin phosphate topical solution usp, 1% isopropyl alcohol propylene glycol sodium hydroxide water clindamycin phosphate clindamycin

Drug Interactions:

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.

Indications and Usage:

Indications and usage clindamycin phosphate topical solution usp, 1% 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 ).

Warnings:

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. antiper Read more...

istaltic 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 Precautions:

General clindamycin phosphate topical solution usp, 1% 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 solution usp, 1% should be prescribed with caution in atopic individuals.

Dosage and Administration:

Dosage and administration apply a thin film of clindamycin phosphate topical solution usp, 1% twice daily to affected area. keep container tightly closed.

Contraindications:

Contraindications clindamycin phosphate topical solution usp, 1% 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.

Adverse Reactions:

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 treatment emergent adverse event solution n = 553(%) gel n=148 (%) lotion 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) # not recorded * of 126 subjects 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 Read more...

). 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.

Adverse Reactions Table:

Number of Patients Reporting Events
Treatment Emergent Adverse Event	Solution n = 553(%)	Gel n=148 (%)	Lotion 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)

Drug Interactions:

Use in Pregnancy:

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.

Pediatric Use:

Pediatric use safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatric Use:

Geriatric use clinical studies for clindamycin phosphate 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.

Overdosage:

Overdosage topically applied clindamycin phosphate topical solution usp, 1% can be absorbed in sufficient amounts to produce systemic effects ( see warnings ).

Description:

Description clindamycin phosphate topical solution usp, 1% contain clindamycin phosphate, usp, at a concentration equivalent to 10 mg clindamycin per milliliter. clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(s)âchloro-substitution of the 7(r)-hydroxyl group of the parent antibiotic lincomycin. the solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide 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 -Î±-d- galacto -octopyranoside 2-(dihydrogen phosphate). strucutre clinda

Clinical Pharmacology:

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 (0â3 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 Read more...

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.

How Supplied:

How supplied clindamycin phosphate topical solution usp, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per millilitre is available in the following size: 60 ml bottle â ndc â 21922-002-01 30 ml bottle â ndc â 21922-002-21 store at controlled room temperature 20Â° to 25Â°c (68Â° to 77Â°f) [see usp]. protect from freezing. to report suspected adverse reactions, contact encube ethicals private limited at 1-833-285-4151or fda at 1-800-fda-1088 or www.fda.gov/medwatch. rx only manufactured by: encube ethicals private limited plot no. c1, madkaim ind. estate, madkaim, post mardol, ponda, goa-403 404, india. distributed by: encube ethicals, inc. 200 meredith avenue, suite 101a, durham, nc 27713 usa rev: 08 august 2020

Package Label Principal Display Panel:

Package label.principal display panel principal display panel - 60ml bottle carton ndc - 21922-002-01 clindamycin phosphate topical solution usp, 1%* solution for topical use only 60 ml rx only store at controlled room temperature 20Â° to 25Â°c (68Â° to 77Â°f) [see usp]. protect from freezing. store in an upright fashion. keep container tightly closed. for external use only. avoid contact with eyes. usual dosage: see accompanying prescribing information. to use enclosed applicator: 1. remove cap and discard. 2. firmly press applicator into bottle. 3. seal firmly by tightening domed-cap. patient information 1. clean and dry the skin area to be treated. 2. apply a thin film of medication to the affected area. use sparingly, avoiding eyes and mouth. if medication accidentally enters eyes, rinse thoroughly with tap water. 3. if using the applicator top, use dabbing motion of the tip rather than a rolling action. if tip becomes dry, invert the bottle and depress tip several times until it becomes moist. *each ml contains clindamycin phosphate equivalent to 10mg/ml (1%) of clindamycin. also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. mfg. lic. no.: manufactured by: encube ethicals pvt. ltd. plot no. c-1, madkaim industrial estate, madkaim, post: mardol, ponda, goa - 403 404, india. distributed by: encube ethicals, inc. 200 meredith avenue, suite 101a durham, nc 27713 usa principal display panel - 60ml bottle label clindamycin phosphate topical solution usp, 1%* ndc 21922-002-01 solution for topical use only 60 ml rx only store at controlled room temperature 20Â° to 25Â°c (68Â° to 77Â°f) [see usp]. protect from freezing. store in an upright fashion. keep container tightly closed. for external use only. avoid contact with eyes. usual dosage: see accompanying prescribing information. patient information 1. clean and dry the skin area to be treated. 2. apply a thin film of medication to the affected area. use sparingly, avoiding eyes and mouth. if medication accidentally enters eyes, rinse thoroughly with tap water. 3. if using the applicator top, use dabbing motion of the tip rather than a rolling action. if tip becomes dry, invert the bottle and depress tip several times until it becomes moist. *each ml contains clindamycin phosphate equivalent to 10mg/ml (1%) of clindamycin. also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. mfg. lic. no.: manufactured by: encube ethicals pvt. ltd. plot no. c-1, madkaim industrial estate, madkaim, post: mardol, ponda, goa - 403 404, india. distributed by: encube ethicals, inc. 200 meredith avenue, suite 101a durham, nc 27713 usa principal display panel - 30ml bottle carton clindamycin phosphate topical solution usp, 1%* ndc 21922- 002 -21 solution for topical use only 30 ml rx only store at controlled room temperature 20Â° to 25Â°c (68Â° to 77Â°f) [see usp]. protect from freezing. keep container tightly closed. for external use only. avoid contact with eyes. usual dosage: see accompanying prescribing information. to use enclosed applicator: 1. remove cap and discard. 2. firmly press applicator into bottle. 3. seal firmly by tightening domed-cap. patient information 1. clean and dry the skin area to be treated. 2. apply a thin film of medication to the affected area. use sparingly, avoiding eyes and mouth. if medication accidentally enters eyes, rinse thoroughly with tap water. 3. if using the applicator top, use dabbing motion of the tip rather than a rolling action. if tip becomes dry, invert the bottle and depress tip several times until it becomes moist. *each ml contains clindamycin phosphate equivalent to 10mg/ml (1%) of clindamycin. also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. mfg. lic. no.: 362 manufactured by: encube ethicals pvt. ltd. plot no. c-1, madkaim industrial estate, madkaim, post: mardol, ponda, goa - 403 404, india. distributed by: encube ethicals, inc. 200 meredith avenue, suite 101a durham, nc 27713 usa principal display panel - 30ml bottle label clindamycin phosphate topical solution usp, 1%* ndc 21922- 002 -21 solution for topical use only 30 ml rx only store at controlled room temperature 20Â° to 25Â°c (68Â° to 77Â°f) [see usp]. protect from freezing. store in an upright fashion. keep container tightly closed. for external use only. avoid contact with eyes. usual dosage: see accompanying prescribing information. patient information 1. clean and dry the skin area to be treated. 2. apply a thin film of medication to the affected area. use sparingly, avoiding eyes and mouth. if medication accidentally enters eyes, rinse thoroughly with tap water. 3. if using the applicator top, use dabbing motion of the tip rather than a rolling action. if tip becomes dry, invert the bottle and depress tip several times until it becomes moist. *each ml contains clindamycin phosphate equivalent to 10mg/ml (1%) of clindamycin. also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. mfg. lic. no.: 362 manufactured by: encube ethicals pvt. ltd. plot no. c-1, madkaim industrial estate, madkaim, post: mardol, ponda, goa - 403 404, india. distributed by: encube ethicals, inc. 200 meredith avenue, suite 101a durham, nc 27713 usa carton-label-30ml.jpg bottle-label-60ml.jpg carton-label-30ml.jpg bottle label 30 ml

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