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| Product NDC Code | 63868-280 | ||||
|---|---|---|---|---|---|
| Drug Name | Antiseptic skin cleanser exidine-2 chg |
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| Type | Brand | ||||
| Pharm Class | Decreased Cell Wall Integrity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| Application Number | NDA019422 | ||||
| Labeler Name | Quality Choice | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient chlorhexidine gluconate 2% 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 cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner. scrub for 1.5 minutes with about 8 mL of product (5 full pumps) with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers rinse thoroughly under running water for 30 seconds wash for an additional 1.5 minutes with 8 mL of product (5 full pumps) and rinse under running water for 30 seconds dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 mL of product (3 full pumps) into cupped hands and wash in a vigorous manner for about 15 seconds rinse and dry thoroughly
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water
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
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.Antiseptic Skin Cleanser Exidine-2 CHG CHLORHEXIDINE GLUCONATE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) COCO DIETHANOLAMIDE LAURAMINE OXIDE WATER CITRIC ACID MONOHYDRATE 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.Package Label NDC 63868-280-02 Chlorhexidine Gluconate 2% Solution Antiseptic Distributed by: C,D,M,A,Inc. Novi, MI 48376 USA qualitychoice.com 2QC02BTLLBL Quality Choice ® Net Wt 2 fl oz (60 mL) NDC 63868-280-08 Quality Choice Antiseptic Skin Cleanser Antiseptic/Antimicrobial Skin Cleanser Chlorhexidine Gluconate 2% Solution Reduces Bacteria on the Skin FOR EXTERNAL USE ONLY TRICLOSAN FREE FDA APPROVED 8.5 fl oz (250 mL) 2 PDP 1 2 3 4 5 6 2QC85 PDP 2QC85DF1 2QC85 DF2 2QC85 DF3
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are allergic to chlorhexidine gluconate or any other ingredient in this product
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.Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents. Warning: This product can expose you th coconut oill diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause sancer.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-935-2362 Monday through Friday 9:00 AM to 4:00 PM EST
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 do not use routinely if you have wounds which involve more than the superficial layers of the skin
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
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 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 ingredient in this product When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 do not use routinely if you have wounds which involve more than the superficial layers of the 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.
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