BACTOSHIELD CHG- chlorhexidine gluconate sponge 
Deb USA, Inc.

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Bactoshield® CHG 4%
Chlorhexidine Gluconate 4% Solution Brush Sponge

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

Principal Display Panel - 25 mL Applicator Box
BACTOSHIELD CHG 
chlorhexidine gluconate sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-816
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)  
LANOLIN (UNII: 7EV65EAW6H)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (PALE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-816-1030 in 1 BOX08/31/201808/31/2021
1NDC:11084-816-0925 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01982208/31/201808/31/2021
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Bajaj Medical , LLC078774921MANUFACTURE(11084-816)
Establishment
NameAddressID/FEIBusiness Operations
Biomed Packaging Systems, Inc.622463388REPACK(11084-816) , RELABEL(11084-816)

Revised: 12/2020
Document Id: 48ec3789-57c6-4834-8a4b-09ae4cb2eb38
Set id: 00018a89-9260-459b-86d3-c58a9bb899ea
Version: 4
Effective Time: 20201214
 
Deb USA, Inc.