NDC 69263-823 Ps1 Aciurgy Pack

Mupirocin 2%, Chlorhexidine Gluconate 4%, Povidone-iodine

NDC Product Code 69263-823

NDC 69263-823-01

Package Description: 1 KIT in 1 KIT * 118 mL in 1 BOTTLE, PLASTIC (0116-1061-04) * 1 mL in 1 PACKET (53329-941-09) * 1 TUBE in 1 CARTON (45802-112-22) > 22 g in 1 TUBE

NDC Product Information

Ps1 Aciurgy Pack with NDC 69263-823 is a a human prescription drug product labeled by Oaklock, Llc. The generic name of Ps1 Aciurgy Pack is mupirocin 2%, chlorhexidine gluconate 4%, povidone-iodine. The product's dosage form is kit and is administered via topical form.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • WATER (UNII: 059QF0KO0R)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • TRIDECYL ALCOHOL (UNII: 8I9428H868)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)

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.

Labeler Name: Oaklock, Llc
Labeler Code: 69263
Marketing Category: UNAPPROVED DRUG OTHER - 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: 10-12-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Ps1 Aciurgy Pack 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

Other

For Dermatologic UseRx Only

-------------------- Mupirocin Ointment USP, 2% --------------------

REFERENCES1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard -Tenth Edition. CLSI document M07-A10 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.3. Finlay JE, Miller LA, Poupard JA. Interpretive criteria for testing susceptibility of staphylococci to mupirocin.


Antimicrob Agents Chemother 1997;41(5):1137-1139.


Made in IsraelManufactured By Perrigo Yeruham 80500, IsraelDistributed ByPerrigo®Allegan, MI 49010 •


www.perrigo.comRev 05-151N200 RC J6

Description

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (


E)-(2


S,3


R,4


R,5


S)-5-[(2


S,3


S,4


S,5


S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2


H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C


26 H


44 O


9 and the molecular weight is 500.62.



The chemical structure is:

Clinical Pharmacology

Application of


14C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption (<1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application.


Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a trial conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency.

Microbiology -

Mupirocin is an antibacterial agent produced by fermentation using the organism


Pseudomonas fluorescens. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA (tRNA) synthetase. Due to this unique mode of action, mupirocin does not demonstrate cross-resistance with other classes of antimicrobial agents.



When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC >512 mcg/mL) has been reported in increasing numbers of isolates of


Staphylococcus aureus and with higher frequency in coagulase-negative staphylococci. Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci. Because of the occurrence of mupirocin resistance in methicillin-resistant


Staphylococcus aureu (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method.


1,2,3Mupirocin is bactericidal at concentrations achieved by topical administration. Mupirocin is highly protein-bound (>97%), and the effect of wound secretions on the MICs of mupirocin has not been determined.Mupirocin has been shown to be active against susceptible strains of


S. aureus and Streptococcus pyogenes, both


in vitro and in clinical trials (see INDICATIONS AND USAGE). The following


in vitro data are available,


but their clinical significance is unknown. Mupirocin is active against most isolates of


Staphylococcus epidermidis.

Indications And Usage

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to:


S. aureus and


S. pyogenes.

Contraindications

This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

Warnings

Avoid contact with the eyes. In case of accidental contact, rinse well with water.In the event of sensitization or severe local irritation from Mupirocin Ointment USP, 2%, usage should be discontinued.Clostridium difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including mupirocin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of


C. difficile.


C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing isolates of


C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.


If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against


C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of


C. difficile, and surgical evaluation should be instituted as clinically indicated.

  • For external use onlyAlergy alert:This product may cause a severe allergic reaction. Symptoms may incloudewheezing/difficulty breathingshockfacial swellinghivesrashif an allergic reaction occurs, stop use and seek medical help right away

For external use only.

Precautions

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.Mupirocin Ointment USP, 2% is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A paraffin-based formulation - *Bactroban Nasal® (mupirocin calcium ointment ) - is available for intranasal use.Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Mupirocin Ointment USP, 2% should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.Mupirocin Ointment USP, 2% should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.

Information For Patients -

Use this medication only as directed by the healthcare provider. It is for external use only. Avoid contact with the eyes. If Mupirocin Ointment USP, 2% gets in or near the eyes, rinse thoroughly with water. The medication should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact the healthcare provider.

Drug Interactions -

The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied.

Carcinogenesis, Mutagenesis, Impairment Of Fertility -

Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.Results of the following studies performed with mupirocin calcium or mupirocin sodium


in vitro and


in vivo did not indicate a potential for genotoxicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks,


Salmonella reversion test (Ames),


Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.


Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m


2 basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

Pregnancy Category B -

Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m


2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers -

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin Ointment USP, 2% is administered to a nursing woman.

Pediatric Use -

The safety and effectiveness of Mupirocin Ointment USP, 2% have been established in the age range of 2 months to 16 years. Use of mupirocin ointment USP, 2% in these age groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment USP, 2% in impetigo in pediatric subjects studied as part of the pivotal clinical trials (see


CLINICAL STUDIES).

Adverse Reactions

The following local adverse reactions have been reported in connection with the use of mupirocin ointment USP, 2%: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of subjects. Systemic allergic reactions, including anaphylaxis, urticaria, angioedema and generalized rash have been reported in patients treated with mupirocin formulations.

Dosage And Administration

A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

Clinical Studies

The efficacy of topical mupirocin ointment USP, 2% in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment USP, 2% (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment USP, 2% and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment USP, 2%. In the second trial, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% 3 times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for mupirocin ointment USP, 2% (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable populations were 100% for both test groups. There were no side effects reported in the group receiving mupirocin ointment USP, 2%.

Pediatrics -

There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment USP, 2% (n=42) and 36% for vehicle placebo (n=49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment USP, 2%. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment USP, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

How Supplied

Mupirocin Ointment USP, 2% is available as follows:22 g tube (NDC 45802-


112-22)


Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].*Bactroban Nasal® is a registered trademark of GlaxoSmithKline.

Active Ingredient

Chlorhexidine gluconate 4% solution

Povidone-Iodine, 10% w/w

Purpose

Antiseptic

Antiseptic

Uses

  • Surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • Healhcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • Patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • Skin wound and general skin cleansing

  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Do Not Use

  • If you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this productin contact with meningesin the genital areaas a preoperative skin preparation of the head or face

  • In the eyeslonger than 1 week unless directed by a physicianon individuals who are allergic or sensitive to iodineor apply over large areas of the body

When Using This Product

  • Keep out of the eyes, ears and mouth. May cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums.if solution should contact these areas, rinse our promptly and thoroughly with waterwounds which involve more than the superficial layers of the skin should not be routinely treatedrepeated general skin cleansing of large body areas should not be done ecept when advised be a health care provider

Stop Use And Ask A Doctor If

Irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

  • Irritation and redness developcondition persists for more than 72 hoursin case of deep or puncture wounds, animal bites or serious burns

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.Surgical hand scrub:wet hands and forearms with waterscrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles amd interdigital spacesa seprate nail cleaner may be usedrinse thoroughlywash for an additional 3 minutes with 5 mL of product and rinse under running waterdry thoroughlyHealthcare personnel handwash:wet hands with waterdispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 secondsrinse and dry thoroughlyPatient preoperative skin preparation:apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towelrepeat procedure for an additional 2 minutes and dry with a sterile towelSkin wound and general skin cleaning:thoroughly rinse the area to be cleaned with waterapply the minimum amount of product necessary to cover the skin or wound area and wash gentlyrinse again thoroughly

  • Clean the affected areaapply a small amount of this product on the area 1 to 3 times daily.may be covered with a sterile bandageif bandaged, let dry first

Other Information

  • Store at 20-25º C (68-77ºF)avoid excessive heat above 40ºC (104ºF)

  • Do not flushprotect from freezing, avoid excessive heat

Inactive Ingredients

Cocamide DEA, fragrance, glucono-delta-lactone, hydroxethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Citric acid, disodium phosphate, water

Keep Out Of Reach Of Children.

If swallowed, get medical assistance or immediately contact a Poison Control Center.

Ps1 Aciurgy Pack

Mupirocin 2%Chlorhexidine Gluconate 4%Povidone-Iodine, USP 10%Gebauer's


® PainEase


NDC 69263-823-01Oaklock LLC

* Please review the disclaimer below.