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NDC 00404-1061-32 Antiseptic Skin Cleanser 20 mg/mL Details

Antiseptic Skin Cleanser 20 mg/mL

Antiseptic Skin Cleanser is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein, Inc.. The primary component is CHLORHEXIDINE GLUCONATE.

Product Information

NDC	00404-1061
Product ID	0404-1061_7abc4c4c-8ab1-fa25-e053-2991aa0a766b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antiseptic Skin Cleanser
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorhexidine Gluconate 4%
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	CHLORHEXIDINE GLUCONATE
Labeler Name	Henry Schein, Inc.
Pharmaceutical Class	Decreased Cell Wall Integrity [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019125
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00404-1061-32 (00404106132)

Pricing Information	N/A
NDC Package Code	0404-1061-32
Billing NDC	00404106132
Package	946 mL in 1 BOTTLE (0404-1061-32)
Marketing Start Date	2003-04-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 78861ded-4134-f6e9-e053-2991aa0a6cb4 Details

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

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

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.

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

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

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.

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.

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

Other information

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.

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

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

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.

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 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 and ask a doctor if

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

Keeo 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.

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

Other information

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

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

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.

Rev 11/2018

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

INGREDIENTS AND APPEARANCE

ANTISEPTIC SKIN CLEANSER

chlorhexidine gluconate 4% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-1061
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-75 LANOLIN (UNII: 09179OX7TB)
WATER (UNII: 059QF0KO0R)
TRIDECYL ALCOHOL (UNII: 8I9428H868)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0404-1061-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2003
2	NDC:0404-1061-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019125	04/02/2003

Labeler - Henry Schein, Inc. (012430880)

Registrant - Xttrium Laboratories, Inc. (007470579)

Name	Address	ID/FEI	Business Operations
Establishment
Xttrium Laboratories		007470579	manufacture(0404-1061)

Revised: 11/2018

Document Id: 7abc4c4c-8ab1-fa25-e053-2991aa0a766b

Set id: 78861ded-4134-f6e9-e053-2991aa0a6cb4

Version: 2

Effective Time: 20181115