BACTOSHIELD CHG CHLORHEXIDINE GLUCONATE SOLUTION- chlorhexidine gluconate solution

Bactoshield CHG by

Drug Labeling and Warnings

Bactoshield CHG by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., 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
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
• skin wound and general skin cleansing

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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
• in contact with meninges
• in the genital area

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
• 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

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)
• avoid 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 1-866-783-0422 Monday through Friday 8:00 AM to 4:30 PM EST

Warning

This product contains a chemical (cocamide DEA) known in the State of California to cause cancer.

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

Bactoshield ®
CHG 4%

deb med®

NDC: 11084-815-24

Surgical Scrub

4% Solution Antiseptic
Chlorhexidine Gluconate

Surgical Scrub

4% CHG

Antimicrobial

REORDER #
1344 - 24

Net Contents: 946mL (32 fl oz)

61341
1344-21H(218)
4BACT32BTLLBLA

INGREDIENTS AND APPEARANCE

BACTOSHIELD CHG  CHLORHEXIDINE GLUCONATE SOLUTION
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-815
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: 11084-815-08	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
2	NDC: 11084-815-24	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
3	NDC: 11084-815-34	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018
4	NDC: 11084-815-03	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	02/01/2018

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	MANUFACTURE(11084-815)