every one Dermawerx Surgical PrePak Generic Name: chlorhexidine gluconate Dosage Form: kit 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. Skin Repair Cream (5% Dimethicone) Drug Facts Active ingredient Dimethicone 5.0% Purpose Skin Protectant Uses 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 gently cleanse and dry affected area apply liberally to affected area as needed. 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, Complex [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6 ), 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. Dermawerx Surgical Pre Pak Dermawerx Surgical PrePak chlorhexidine gluconate pre-surgical kit kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69329-260 Packaging # Item Code Package Description 1 NDC:69329-260-01 1 KIT in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 237 mL Part 2 1 TUBE 118 mL Part 1 of 2 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 GLUCONOLACTONE PEG-75 LANOLIN COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL LAURAMINE OXIDE WATER TRIDECYL ALCOHOL Packaging # Item Code Package Description 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 2 of 2 SKIN REPAIR COMPLEX dimethicone cream Product Information Item Code (Source) NDC:69329-253 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 BUTYLENE GLYCOL SAFFLOWER OIL CETYL ALCOHOL KUKUI NUT OIL ALOE VERA LEAF CHLORPHENESIN DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE LEVOMENOL CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES MALTODEXTRIN PYRIDOXINE HYDROCHLORIDE TROLAMINE STEARIC ACID HYALURONATE SODIUM PHENOXYETHANOL NIACINAMIDE GINGER PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PEG-100 STEARATE .ALPHA.-TOCOPHEROL ACETATE, DL- CAPRYLYL GLYCOL METHYLPARABEN WATER Packaging # Item Code Package Description 1 NDC:69329-253-02 118 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 NDA NDA019125 12/10/2015 Labeler - Patchwerx Labs, Inc. (079584480) Revised: 12/2015 Patchwerx Labs, Inc. 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... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More seems to be
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