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NDC 00116-0506-02 BD E-Z Scrub 20 mg/mL Details

BD E-Z Scrub 20 mg/mL

BD E-Z Scrub is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is CHLORHEXIDINE GLUCONATE.

Product Information

NDC	00116-0506
Product ID	0116-0506_b17f807f-8272-5e52-e053-2995a90ac190
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	BD E-Z Scrub
Proprietary Name Suffix	n/a
Non-Proprietary Name	chlorhexidine gluconate
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	Xttrium Laboratories, Inc.
Pharmaceutical Class	Decreased Cell Wall Integrity [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019422
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00116-0506-02 (00116050602)

Pricing Information	N/A
NDC Package Code	0116-0506-02
Billing NDC	00116050602
Package	946 mL in 1 BOTTLE (0116-0506-02)
Marketing Start Date	2001-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a6239ab-2c7f-72b2-e054-00144ff88e88 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

chlorhexidine gluconate 2% solution

Purpose

surgical hand scrub

healthcare personnel handwash

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

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 are allergic to chlorhexidine gluconate or any other ingredient in this 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
do not use routinely if you have wounds which involve more than the superficial layers of the skin

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 forearms with water
scrub for 3 minutes with 5 ml of solution (4 full strokes) and a wet brush paying close attention to the nails, cuticles, and interdigital space
a separate nail cleaner may be used
rinse thoroughly
wash for an additional 3 minutes with 5 ml of solution (4 full strokes) and rinse under running water
dry thoroughly

Healthcare personnel handwash:

wet hands with water
dispense 5 ml of solution (4 full strokes) into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
dry thoroughly

Other information

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

Inactive ingredients

citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

call 1-800-453-4538 Monday through Friday 8 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

NDC 17271-506-02

BD E-Z Scrub

Chlorhexidine Gluconate 2% Solution Antiseptic

REF 372416

Foreign Patents and Pantents Pending

U.S. Patent 6,427,875

Chlorhexidine Gluconate

32 fl oz (946 mL)

INGREDIENTS AND APPEARANCE

BD E-Z SCRUB

chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0116-0506
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0116-0506-02	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2001

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019422	04/01/2001

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Name	Address	ID/FEI	Business Operations
Establishment
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0506)

Revised: 10/2020

Document Id: b17f807f-8272-5e52-e053-2995a90ac190

Set id: 4a6239ab-2c7f-72b2-e054-00144ff88e88

Version: 5

Effective Time: 20201012

Search by Drug Name or NDC

NDC 00116-0506-02 BD E-Z Scrub 20 mg/mL Details

BD E-Z Scrub 20 mg/mL

Product Information

Package

Package Images

NDC 00116-0506-02 (00116050602)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4a6239ab-2c7f-72b2-e054-00144ff88e88 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

When using this product

Directions

Surgical hand scrub:

Healthcare personnel handwash:

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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