BACTOSHIELD CHG- chlorhexidine gluconate solution 
Xttrium Laboratories, Inc.

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Bactoshield CHG ® 4%

Chlorhexidine Gluconate Solution

Drug Facts

Active ingredient

chlorhexidine gluconate 4% solution

Purposes

surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing

Uses

Warnings

For external use only

Allergy alert:

This product may cause a sever 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 deadness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out prompty 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

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 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 with water
  • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

  • apply product liberally to surgical site and swab for at least 2 minutes
  • dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

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

Inactive ingredients

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

Questions or comments?

Call 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM EST

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.

Bactoshield ® CHG 4%

NDC 11084-815-03

Surgical Scrub

Chlorhexidine Cluconate 4% Solution Antiseptic

Non-sterile Solution

Surgical Scrub

4% CHG

Antimicrobial

For Single-Use

Net Contents: 118 mL (4 fl oz)

REORDER #1344-39

1344-52F(319)

61346

4BACT04BTLLBLD

4BACT04 PDP

4BACT04 DF1

4BACT04 DF2

4BACT04 DF3

Bactoshield ® CHG 4%

NDC 11084-815-34

Surgical Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

Surgical Scrub

4% CHG

Antimicrobial

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

REORDER #1344-33

61340

1344-31H(319)

4BACT16BTLLBLE

4BACT16 PDP

4BACT16 DF1

4BACT16 DF2

4BACT16 DF3

Bactoshield ® CHG 4%

NDC 11084-815-24

Surgical Scrub

4% Solution Antiseptic Chlorhexidine Gluconate

Surgical Scrub

4% CHG

Antimicrobial

Net Contents: 32 fl oz (946 mL)

REORDER #1344-24

61341

1344-21H(319)

4BACT32BTLLBLB

4BACT32

Bactoshield ® CHG 4%

NDC 11084-815-08

Surgical Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

Surgical Scrub

4% CHG

Antimicrobial

Net Contents: 128 fl oz (1 Gal) (3.78 Liters)

REORDER #1344-08

1344-06G(319)

51690

4BACT1GLBLB

4BACT1G PDP

4BACT1G DF1

4BACT1G DF2

BACTOSHIELD CHG 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-1344
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-1344-083780 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
2NDC:0116-1344-24946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
3NDC:0116-1344-34473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
4NDC:0116-1344-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/04/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912510/04/1999
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-1344)

Revised: 11/2019
Document Id: 96b02784-bec7-519c-e053-2a95a90a74d5
Set id: 4a6403ad-fa5e-2b4a-e054-00144ff8d46c
Version: 6
Effective Time: 20191106
 
Xttrium Laboratories, Inc.