BACTOSHIELD CHG- chlorhexidine gluconate 4% 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

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
• 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 cleaning:

• 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 1-800-587-3721
Monday through Friday 8:00 AM to 4:30 PM CST

Laundering/Cleaning Instructions:

Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

Packaging

SCJ Professional

Healthcare

Bactoshield

CHG 4%

NDC: 11084-039-24

Surgical Scrub

Chlorhexidine Gluconate 4% Solution Antiseptic

Surgical Scrub

4% CHG

Antimicrobial

Net Contents:32 fl oz (946 mL)

REORDER#

1344-24

SAP # 4000011063

1344-21L(123)

4SCJ32BTLLBLA

deb

SKIN CARE

Manufactured for: SCJ Professional USA, Inc.

Charlotte, NC 28217

1-866-783-0422 www.scjp.com

WARNING: Cancer -- www.P65Warnings.ca.gov. Keep from freezing.

INGREDIENTS AND APPEARANCE

BACTOSHIELD CHG 
chlorhexidine gluconate 4% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-0039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-75 LANOLIN (UNII: 09179OX7TB)
TRIDECYL ALCOHOL (UNII: 8I9428H868)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0039-24	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2022	11/30/2027

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	11/22/2022	11/30/2027

Labeler - Xttrium Laboratories, Inc. (007470579)