BACTOSHIELD CHG- chlorhexidine gluconate sponge

Bactoshield CHG by

Drug Labeling and Warnings

Bactoshield CHG by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., Bajaj Medical , LLC, Biomed Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Use

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use only

Allergy alert

This product may cause a severe allergic realction. Symptoms may include:

• wheezing/difficulty breathing
• hives
• shock
• rash
• facial swelling

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

• if you are allergic to chlorhexidine gluconate or any other ingredients in this product.

When using this product

• keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter or allowed to remain.
• if contact occurs, rinse with cold water right away
• do not use routinely if you have wounds which involve more than the superficial layers of the skin

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.
• open package
• wet hands and forearms to the elbows with warm water
• clean under nails with nail pick provided. Nails should be maintained with a 1 millimeter free edge
• wet sponge and squeeze to work up lather
• scrub thoroughly for 3 minutes, paying particular attention to the nails, cuticles and interdigital spaces. Use the brush side to clean the nails, cuticles and interdigital spaces between the fingers and the sponge side to scrub the hands and forearms
• rinse thoroughly with warm water
• scrub for an additional 3 minutes using the sponge side
• discard brush-sponge
• rinse hands and forearms thoroughly and dry with a sterile towel

Other information

• store between 20-25°C (68-77°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

cocamide DEA, fragrance POFL 147, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions?

1-866-783-0422 (Monday to Friday 8 AM - 5 PM EST)

PRINCIPAL DISPLAY PANEL - 25 mL Applicator Box

Bactoshield® CHG 4%

deb med®

NDC: 11084-816-10

Chlorhexidine Gluconate 4% Solution
Surgical Hand Scrub

Surgical Scrub
4% CHG
Antimicrobial

REORDER #
1364-PJ

INGREDIENTS AND APPEARANCE

BACTOSHIELD CHG 
chlorhexidine gluconate sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-816
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)
LANOLIN (UNII: 7EV65EAW6H)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW (PALE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-816-10	30 in 1 BOX	08/31/2018
1	NDC: 11084-816-09	25 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019822	08/31/2018

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Bajaj Medical , LLC		078774921	MANUFACTURE(11084-816)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Packaging Systems, Inc.		622463388	REPACK(11084-816) , RELABEL(11084-816)