Package Label And Principal Display Panel

Package Label And Principal Display Panel
SPL v3
SPL
SPL Set ID 78861ded-4134-f6e9-e053-2991aa0a6cb4
Route
TOPICAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Chlorhexidine gluconate 4% solution


Medication Information

Warnings and Precautions

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.

Indications and Usage

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 and Administration

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

Description

Chlorhexidine gluconate 4% solution

Section 44425-7

store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition

Section 50567-7

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

Section 50570-1

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

Section 51727-6

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Section 51945-4

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

Section 53413-1

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Section 55105-1

Antiseptic

Section 55106-9

Chlorhexidine gluconate 4% solution

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Chlorhexidine gluconate 4% solution

Section 60561-8 (60561-8)

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


Raw Label Data

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