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| Product NDC Code | 0116-0575 | ||||||||||||||||
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| Drug Name | Hibiclens |
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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 | NDA017768 | ||||||||||||||||
| Labeler Name | Xttrium Laboratories, Inc. | ||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Chlorhexidine gluconate solution 4.0% w/v
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. skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly. surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL (4 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly. healthcare personnel handwash. Wet hands with water. Dispense about 5 mL (4 pumps) of the product 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.fragrance, gluconolactone, isopropyl alcohol 4% w/v, lauramine oxide, poloxamer 237, purified water and red 40
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 antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub healthcare personnel handwash
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.Hibiclens Chlorhexidine Gluconate 4% CHLORHEXIDINE GLUCONATE CHLORHEXIDINE LAURAMINE OXIDE WATER FD&C RED NO. 40 GLUCONOLACTONE ISOPROPYL ALCOHOL POLOXAMER 237
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.Principal Display Panel (Labels) NDC 0234-0575-04 Hibiclens Chlorhexidine gluconate solution 4.0% w/v Antiseptic Skin Cleanser Persistent Effect Great for Hand Hygiene General Skin Cleansing Helps reduce bacteria that potentially can cause disease 4oz (118mL) NDC 0234-0575-91 Hibiclens Chlorhexidine gluconate solution 4.0% w/v Antiseptic Skin Cleanser Persistent Effect Great for Hand Hygiene General Skin Cleansing Helps reduce bacteria that potentially can cause disease 1 gal (3.79L) NDC 0234-0575-32 Hibiclens Chlorhexidine gluconate solution 4.0% w/v Antiseptic Skin Cleanser Persistent Effect Great for Hand Hygiene General Skin Cleansing Helps reduce bacteria that potentially can cause disease 32oz (946mL) NDC 0234-0575-16 Hibiclens Chlorhexidine gluconate solution 4.0% w/v Antiseptic Skin Cleanser Persistent Effect Great for Hand Hygiene General Skin Cleansing Helps reduce bacteria that potentially can cause disease 16oz (473 mL) NDC 0234-0575-80 Hibiclens Chlorhexidine gluconate solution 4.0% w/v Antiseptic Skin Cleanser Persistent Effect Great for Hand Hygiene General Skin Cleansing Helps reduce bacteria that potentially can cause disease with foam pump Replace cap after use 8oz (236mL) NDC 0234-0575-08 HIbiclens Chlorhexidine gluconate solution 4.0% w/v Antiseptic Skin Cleanser Persistent Effect Great for Hand Hygiene General Skin Cleansing Helps reduce bacteria that potentially can cause disease 8oz (236mL) NDC 0234-0575-41 Hibiclens Chlorhexidine gluconate solution 4.0% w/v Antiseptic Skin Cleanser Persistent Effect Great for Hand Hygiene General Skin Cleansing Helps reduce bacteria that potentially can cause disease with foam pump Replace cap after use 4fl oz (118mL) Hibiclens 4oz Bottle label Hibiclens 1 gallon bottle label Hibiclens 32oz bottle label Hibiclens 16oa bottle label Hibiclens 8oz Fm bottle label Hibiclens 8oz Bottle label Hibiclens 4oz FM
Hibiclens 16oz Shelf Carton label Hibiclens 8oz Shelf Carton label Hibiclens 8oz fm Shelf Carton label Hibiclens 4oz Shelf Carton label
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 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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with the meninges in the genital area
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.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.Allergy alert This product may cuase 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.
Other information store between 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-843-8497
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 contact occurs in any of these areas, rinse with cold water right away wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general cleansing of large body areas should not be done except when advised by a health care provider
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 cuase 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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with the meninges in the genital area 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 contact occurs in any of these areas, rinse with cold water right away wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general cleansing of large body areas should not be done except when advised by a health care provider
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