FDA Label for Antiseptic Skin Cleanser
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER SAFETY INFORMATION
- KEEO OUT OF REACH OF CHILDREN.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- CONTENT OF LABELING
- PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL
Antiseptic Skin Cleanser Product Label
The following document was submitted to the FDA by the labeler of this product Henry Schein, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Chlorhexidine gluconate 4% solution
Chlorhexidine gluconate 4% solution
Purpose
Antiseptic
Antiseptic
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
- 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
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
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
For external use only
Allergy alert: This product may cause a severe allergic reaction. Symptoms may include:
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 wth the meninges
- in the gential area
- 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 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
- 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 And Ask A Doctor If
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition
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.
Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- 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
- 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
- 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
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- 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
- 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
- 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
Surgical hand scrub:
Healthcare personnel handwash:
Skin wound and general skin cleansing:
Surgical hand scrub:
Healthcare personnel handwash:
Skin wound and general skin cleansing:
Other Information
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
Inactive Ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.
cocamide DE, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.
Questions Or Comments?
call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
Other Safety Information
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
Keeo Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
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
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
* Please review the disclaimer below.