SCRUB CARE EXIDINE -4 CHG- chlorhexidine gluconate liquid 
Xttrium Laboratories, Inc.

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Drug Facts CareFusion 4%

Active Ingredients

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

patient preoperatve skin preparation: for the preparation of the patient's skin prior to surgery

skin wound and general skin cleansing

Warnings

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 with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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:

Healthcare personnel handwash:

Patient preoperative skin preparation:

Skin wound and general skin cleansing:

Other information

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

Package label and principal display panel

NDC 0116-2994-04

REF 29900-404

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contans:

4% Chlorhexidine Gluconate

For External Use Only

For Single Use Only

Distributed By

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10096 Rev. A

4CFB04BTLBLE

Net Contents: 4 fl oz (118 mL)

4CF04 PDP

4CF04 DF1

4CF04 DF2

4CF04 DF3

4CF04 DF4

NDC 0116-2994-05

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhxidine Gluconate

For External Use Only

For Single Use Only

Distributed By

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10081 Rev. A

ETOBTLLBLE

Net Contents: 4 fl oz (118 mL)

4ETO PDP

NDC 0116-2994-08

REF 29900-408

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate

4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

For External Use Only

Distributed by

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10097 Rev. A

4CF08BTLBLE

Net Contents: 8 fl oz (237 mL)

4CF08 PDP

NDC 0116-2994-16

REF 29900-416

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate

4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate

For External Use Only

Distributed By

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10098 Rev. A

4CFB16BTLLBLC

Net Contents: 16 fl oz (1 pt) (473 mL)

4CF16 PDP

NDC 0116-2994-17

REF 29900-416P

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate

4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate

For External Use Only

Distributed By

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10099 Rev. A

4CFB16BTLPLBLC

Net Contents: 16 fl oz (1 pt) (473 mL)

4CF16P PDP

NDC 0116-2994-32

REF 29900-432

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate

4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

For External Use Only

Distributed by

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10100 Rev. A

4CFB32BTLLBLC

Net Contents: 32 fl oz (1 qt) (946 mL)

4CF32

NDC 0116-2994-33

REF 29900-432P

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate

4% Solution

Antiseptic

Contains: 4% Chlorhexidine Gluconate

For External Use Only

Distributed by

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10101 Rev. A

4CF32BTLPLBLC

Net Contents: 32 fl oz (1 qt) (946 mL)

4CF32P

NDC 0116-2994-01

REF 29900-401

BD Scrub Care™

Exidine™-4 CHG 4%

Chlorhexidine Gluconate

4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate

For External Use Only

Distributed by

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10095 Rev. A

4CF1GBTLLBLD

Net Contents: 128 fl oz (1 gal) (3.8 L)

4CF1G PDP

SCRUB CARE  EXIDINE -4 CHG
chlorhexidine gluconate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-2994
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-2994-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2012
2NDC:0116-2994-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2012
3NDC:0116-2994-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2012
4NDC:0116-2994-17473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2012
5NDC:0116-2994-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2012
6NDC:0116-2994-33946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2012
7NDC:0116-2994-013786 mL in 1 JUG; Type 0: Not a Combination Product11/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912511/01/2012
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-2994)

Revised: 6/2020
Document Id: a7bcc492-b3bb-6a6c-e053-2995a90a345a
Set id: 17253827-2b20-2f9f-e054-00144ff8d46c
Version: 3
Effective Time: 20200610
 
Xttrium Laboratories, Inc.