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| Product NDC Code | 0404-1061 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antiseptic skin cleanser |
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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 | NDA019125 | ||||||
| Labeler Name | Henry Schein, Inc. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Chlorhexidine gluconate 4% solution
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 cause irritation or chemical burns. Surgical hand scrub: wet hands and forwarms 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 seperate 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 Skin wound and general skin cleansing: 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
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 about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces a seperate 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 Skin wound and general skin cleansing: 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.
Inactive ingredients cocamide DE, 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 skin wound and general skin cleansing
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 skin wound and general skin cleansing
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% COCO DIETHANOLAMIDE GLUCONOLACTONE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL LAURAMINE OXIDE PEG-75 LANOLIN WATER 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.431-0032 Henry Schein® Maxiclens Antiseptic Skin Cleasner (Chlorhexidine Gluconate 4%) FOR EXTERNAL USE ONLY Net Contents 32 fl oz (1qt)(946-mL) Made in U.S.A Distributed By HENRY SCHEIN INC. 135 Duryea Road Melville, NY 11747 USA 4MAX32BTLLBL
Content of Labeling Content of Labeling Drug Facts 1 Drug Facts 2
Package label and principal display panel NDC 0404-1061-01 431-0099 HENRY SCHEIN ® Maxiclens Antiseptic Skin Cleanser (Chlorhexidine Gluconate 4%) FOR EXTERNAL USE ONLY Net Contents 128 fl oz (1 gal) (3.785 L) Made in U.S.A. Distributed By HENRY SCHEIN INC. 135 Duryea Road Melville, NY 11747 USA 4MAX1GBTLLBL 1-gallon PDP 1-gallon drug facts 1-gallon drug facts 2
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 wth the meninges in the gential area
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.
Keeo 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, such as chlorine bleach. Rinse completely and use only non-chlorine detergents. 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 Rev 7/2018
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents. 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 Rev 11/2018
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 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
Questions or comments? call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
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
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 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 advised by a health care provider
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 cuase 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 advised by a health care provider
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)
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/difficuly breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away.
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.
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