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| Product NDC Code | 76420-535 | ||||
|---|---|---|---|---|---|
| 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 | Asclemed USA, 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.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 5mL of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly. healthcare personnel handwash . Wet hand with water. Dispense about 5mL 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 to reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub healthcare peronnel handwash
Purpose
Information about the drug product’s indications for use.Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Hibiclens Chlorhexidine Gluconate POLOXAMER 237 GLUCONOLACTONE LAURAMINE OXIDE ISOPROPYL ALCOHOL WATER FD&C RED NO. 40 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.LABEL
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.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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
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 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
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 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.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.
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