BACTOSHIELD CHG- chlorhexidine gluconate solution

Bactoshield CHG by

Drug Labeling and Warnings

Bactoshield CHG by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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 preoperative skin preparation: 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 sever 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 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

• 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 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

• store at 20-25°C (68-77°F)
• void 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 1-800-548-4873 Monday through Friday 8:00 AM to 4:30 PM EST

OTHER SAFETY INFORMATION

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

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

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

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

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

INGREDIENTS AND APPEARANCE

BACTOSHIELD CHG 
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-1344
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-1344-08	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/04/1999
2	NDC: 0116-1344-24	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/04/1999
3	NDC: 0116-1344-34	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/04/1999
4	NDC: 0116-1344-03	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/04/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	10/04/1999

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-1344)