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| Product NDC Code | 68599-5400 | ||||
|---|---|---|---|---|---|
| Drug Name | Chlorhexidine gluconate |
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| Type | Brand | ||||
| Pharm Class | Decreased Cell Wall Integrity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | NDA019125 | ||||
| Labeler Name | McKesson | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Chlorhexidine gluconate 4% solution
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions use with care in premature infants or infants under 2 months of age. These products may causeirritation or chemical burns. Surgical hand s crub: 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 surgery skin wound and general skin cleansing Skin wound and general skin cleansing
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.CHLORHEXIDINE GLUCONATE ANTISEPTIC SKIN CLEANSER COCO DIETHANOLAMIDE PEG-75 LANOLIN GLUCONOLACTONE HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) LAURAMINE OXIDE WATER ISOPROPYL ALCOHOL TRIDECYL ALCOHOL CHLORHEXIDINE GLUCONATE CHLORHEXIDINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.NDC 68599-5400-2 McKesson Antiseptic Skin Cleanser 4% CHLORHEXIDINE GLUCONATE SOLUTION A non-sterile solution that reduces the number of microorganisms on the skin prior to surgery or patient care. 0.5 fl oz (15 mL) 50 PER BOX FOR SINGLE-USE MFR # 16-CHG15 16-CHG15
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 68-77ºF (20-25°C) avoid excessive heat above 104°F (40°C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? General Questions? Call 1-800-777-4908 Technical Support? Call 1-800-587-3721
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to chlorhexidine gluconate or any other ingredients in this product 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 the skin Stop use and ask doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only Allergy Alert This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API