Label: BACTOSHIELD CHG CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution
- NDC Code(s): 11084-038-03
- Packager: SC Johnson Professional USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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 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
- 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 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
-
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 under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
- scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
- rinse thoroughly under running water for 30 seconds
- wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
- 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
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
Bactoshield®
CHG 2%Surgical Scrub
Chlorhexidine Gluconate 2% Solution Antiseptic
Non-Sterile SolutionSCJ PROFESSIONAL
HEALTHCARENDC 11084-038-03
Surgical Scrub
2% CHG
Antimicrobial
REORDER #
1322-39SAP # 4000011062
1322-52J(622)
2SCJ04BTLLBLdeb
SKIN CARENet Contents:
4 fl oz (118 mL)For Single Use
-
INGREDIENTS AND APPEARANCE
BACTOSHIELD CHG CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) HYDROXYETHYL CELLULOSE (100 MPA.S At 2%) (UNII: R33S7TK2EP) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11084-038-03 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 12/01/2022 Labeler - SC Johnson Professional USA, Inc. (607378015) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 MANUFACTURE(11084-038)