SCRUB CARE EXIDINE -4 CHG- chlorhexidine gluconate liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)
Available from:
Xttrium Laboratories, Inc.
INN (International Name):
CHLORHEXIDINE GLUCONATE
Composition:
CHLORHEXIDINE GLUCONATE 4 mg in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - surgical hand scrub: significantly reduces the number of microorganisms on the hand and forearms prior to surgery or patient care - healthcare personnel hand wash: helps reduce bacteria that potentially can cause disease
Authorization status:
New Drug Application
Authorization number:
0116-4444-30, 0116-4444-31

SCRUB CARE EXIDINE -4 CHG- chlorhexidine gluconate liquid

Xttrium Laboratories, Inc.

----------

Drug Facts 4% 30 oz

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purpos es

Antiseptic

Us es

surgical hand scrub: significantly reduces the number of microorganisms on the hand and forearms

prior to surgery or patient care

healthcare personnel hand wash: 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 doctor

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

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

Direction

use with care in premature infants or infants under 2 months of age. These products may cause

irritation or chemical burns.

irritation or chemical burns.

Surgical hand scrub:

wet arms 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 separate 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 water

dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds

rinse and dry thoroughly.

Other Information

Store at 20-25º C (68-77ºF)

Avoid excessive heat above 40ºC (104ºF)

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine

oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

1-800-587-3721 (Mon. - Fri. 8:00 AM - 4:30 PM CST)

Principal Display Panel

Cat. 4CHG4

NDC 0116-4444-30

Scrub Care

Exidine -4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

For External Use Only

Distributed by:

CareFusion, Inc.

Vernon Hills, IL 60061 USA

51-10104 4CF30BTLLBLA

Net Contents: 30 fl oz (887 mL)

To Install

1. Twist to remove plug from back of dispenser spout.

2. Seat dispenser into bracket, taking care to insert the open air inlet into proper receptacle.

3. Twist to remove plug from end of spout.

To Remove

1. Hold bracket against the wall and pull the empty dispenser straight forward.

2. Discard entire bottle and spout.

principal display panel media

Cat. 4CHG4

NDC 0116-4444-30

Scrub Care®

Exidine® -4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhexidine Gluconate

For External Use Only

Distributed By

CareFusion, Inc.

Vernon Hills, IL 60061 USA

4CF30BTLBLB

Cat. 4CHG4-FM

NDC 0116-4444-31

Scrub Care®

Exidine® -4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhexidine Gluconate

For External Use Only

Distributed By

CareFusion, Inc.

Vernon Hills, IL 60061 USA

4CHG30BTLFMLBLB

SCRUB CARE EXIDINE -4 CHG

chlorhexidine gluconate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 116 -4444

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RHEXIDINE GLUCO NATE (UNII: MOR8 4MUD8 E) (CHLORHEXIDINE -

UNII:R4KO0 DY52L)

CHLORHEXIDINE

GLUCONATE

4 mg

in 10 0 mL

Xttrium Laboratories, Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

LAURAMINE O XIDE (UNII: 4F6 FC4MI8 W)

CO CO DIETHANO LAMIDE (UNII: 9 20 0 5F9 72D)

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

HYDRO XYETHYL CELLULO SE ( 2 0 0 0 CPS AT 1%) (UNII: S38 J6 RZN16 )

TRIDECYL ALCO HO L (UNII: 8 I9 428 H8 6 8 )

PEG-7 5 LANO LIN (UNII: 0 9 179 OX7TB)

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 116 -4444-

8 8 7 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

11/0 1/20 12

2

NDC:0 116 -4444-

8 8 7 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

11/0 1/20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 19 125

11/0 1/20 12

Labeler -

Xttrium Laboratories, Inc. (007470579)

Registrant -

Xttrium Laboratories, Inc. (007470579)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Xttrium Labo rato ries, Inc.

0 0 7470 579

ma nufa c ture (0 116 -4444)

Revised: 7/2018

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