service or product [1.1:1024 mcg/mL) has been reported in some strains of S. aureus and coagulase-negative staphylococci. Mupirocin is bactericidal at concentrations achieved by topical administration. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally 8-fold to 30-fold higher than the minimum inhibitory concentration (MIC). In addition, 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 most strains of S. aureus and Streptococcus pyogenes , both in vitro and in clinical studies (see INDICATIONS AND USAGE ). The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus . 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 individuals with a history of sensitivity reactions to any of its components. WARNINGS Mupirocin Ointment USP, 2% is not for ophthalmic use. PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Mupirocin Ointment USP, 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted. 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. Information for Patients - Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. The medication should be stopped and your healthcare practitioner contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner. 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: Teratogenic Effects - 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 studies of mupirocin ointment USP, 2% in impetigo in pediatric patients 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 patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. Systemic reactions to mupirocin ointment USP, 2% have occurred rarely. 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 two studies. In the first, patients with impetigo were randomized to receive either mupirocin ointment USP, 2% or vehicle placebo three times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients 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 study, patients with impetigo were randomized to receive either mupirocin ointment USP, 2% three times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) 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 patients included) were 93% for mupirocin ointment USP, 2% (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups. There were no side effects reported in the group receiving mupirocin ointment. Pediatrics - There were 91 pediatric patients aged 2 months to 15 years in the first study 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 study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment USP, 2%. The age range of the pediatric patients 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 gram 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. Chlorhexidine Gluconate Solution, 4% Drug Facts Active ingredient Chlorhexidine Gluconate 4% solution Purpose Antiseptic Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: for the preparation of the patient's skin prior to surgeryskin wound and general skin cleansing skin wound and general skin cleansing Warnings For external use only. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in contact with meninges in the genital area as a preoperative skin preparation of the head or face When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. 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 and infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleaning: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 40ºC (104ºF) Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol. DermacinRx Skin Repair Complex (Dimethicone 5.0%) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses for the treatment and/or prevention of diaper rash temporarily protects and helps relieve chapped or cracked skin Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions apply cream liberally as needed Other information protect from freezing avoid excessive heat Inactive ingredients Aleurites moluccana seed oil, Aloe barbadensis ( Aloe vera ) leaf juice, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, chlorphenesin, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, DermacinRx Complex [consisting of: bisabolol, calcium pantothenate (vitamin B 5 ), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B 3 ), pyridoxine HCl (vitamin B 6 ), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, purified water, sodium hyaluronate, stearic acid, triethanolamine. Silicone Tape Uses To be applied to wounds or scars as a protective silicone barrier. As a dressing for abrasions, surgical wounds, donor sites, lacerations, ulcers, skin tears, superficial partial thickness burns, venous leg ulcers. As a dressing/securement for IV related uses, pressure ulcers, skin care, and wound care Precautions Do not use if you are allergic to silicone Keep out of reach of children Directions for use Apply tape to wound or scar as needed or as directed by your physician. Remove tape, wash area, and apply new tape at least every 24 hours. Gauze Pads (sterile) DermacinRx Clorhexacin - carton DermacinRx Clorhexacin mupirocin ointment kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59088-391 Packaging # Item Code Package Description 1 NDC:59088-391-00 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 22 g Part 2 1 BOTTLE, PLASTIC 237 mL Part 3 1 TUBE 118 mL Part 1 of 3 MUPIROCIN mupirocin ointment Product Information Item Code (Source) NDC:45802-112 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUPIROCIN (MUPIROCIN) MUPIROCIN 20 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOLS Packaging # Item Code Package Description 1 1 TUBE in 1 KIT 1 NDC:45802-112-22 22 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065123 Part 2 of 3 ANTISEPTIC SKIN CLEANSER chlorhexidine gluconate solution Product Information Item Code (Source) NDC:0116-1061 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL LAURAMINE OXIDE WATER TRIDECYL ALCOHOL GLUCONOLACTONE PEG-75 LANOLIN Packaging # Item Code Package Description 1 1 BOTTLE, PLASTIC in 1 KIT 1 NDC:0116-1061-08 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 Part 3 of 3 SKIN REPAIR COMPLEX dimethicone cream Product Information Item Code (Source) NDC:59088-333 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (DIMETHICONE) Dimethicone 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength KUKUI NUT OIL ALOE VERA LEAF BUTYLENE GLYCOL CAPRYLYL GLYCOL SAFFLOWER OIL CETYL ALCOHOL CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS SEED OLEOSOMES MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- GINGER PEG-100 STEARATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PHENOXYETHANOL WATER HYALURONATE SODIUM STEARIC ACID TROLAMINE Packaging # Item Code Package Description 1 1 TUBE in 1 KIT 1 NDC:59088-333-08 118 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065123 06/02/2016 Labeler - PureTek Corporation (785961046) Revised: 06/2016 PureTek Corporation Print this page]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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