Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% HENRY SCHEIN, INC. FDA Approved 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
FunFoxMeds box
Route
TOPICAL
Applications
NDA019125

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Chlorhexidine gluconate 4% solution Active ingredient Chlorhexidine gluconate 4% solution
Inactive Ingredients
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.
Strengths
4 %
Quantities
01 count
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
UNII
MOR84MUD8E
Packaging

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

Package Descriptions
  • 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

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose Antiseptic Purpose Antiseptic

Do Not Use

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

When Using

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

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

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.

Storage & Handling

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)

Questions

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


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