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| Product NDC Code | 53329-994 | ||||
|---|---|---|---|---|---|
| Drug Name | Foaming hand wash |
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| Type | Brand | ||||
| Pharm Class | Decreased Cell Wall Integrity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1245230 | ||||
| Application Number | NDA019422 | ||||
| Labeler Name | Medline Industries, LP | ||||
| 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 with water • scrub for 3 minutes with 5 mL of product (7 strokes) and a wet brush, paying close attention to the nails, cuticles and skin between the fingers • a separate nail cleaner may be used • rinse thoroughly • wash for an additional 3 minutes with 5 mL of product (7 strokes) and rinse under running water and dry thoroughly Healthcare personnel handwash: • wet hands with water • dispense 5 mL of product (7 strokes) into cupped hands and wash in a vigorous manner for 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.foaming hand wash chlorhexidine gluconate CHLORHEXIDINE GLUCONATE CHLORHEXIDINE COCO DIETHANOLAMIDE LAURAMINE OXIDE ISOPROPYL ALCOHOL HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) CITRIC ACID MONOHYDRATE WATER
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 Label front Label back
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.Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA www.medline.com 1-800-MEDLINE REF: HHCHG1000FM V2 RA22XLI
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.
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.Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
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