Label: BACTOSHIELD CHG- chlorhexidine gluconate 4% solution
- NDC Code(s): 0116-0039-03
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 29, 2023
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- 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 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
Patient preoperative skin preparation:
- apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
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
- Inactive ingredients
- Questions or comments?
- Laundering/Cleaning Instructions:
-
Packaging
SCJ Professional
Healthcare
Bactoshield
CHG 4%
NDC 11084-039-03
Surgical Scrub
Chlorhexidine Gluconate 4% Solution Antiseptic
Non-Sterile Solution
Surgical Scrub
4% CHG
Antimicrobial
REORDER#
1344-39
SAP # 4000011061
1344-52J(123)
4SCJ04BTLLBLA
deb
SKIN CARE
For Single Use
Net Contents:
4 fl oz (118 mL)
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.
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INGREDIENTS AND APPEARANCE
BACTOSHIELD CHG
chlorhexidine gluconate 4% solutionProduct 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) GLUCONOLACTONE (UNII: WQ29KQ9POT) WATER (UNII: 059QF0KO0R) COCO DIETHANOLAMIDE (UNII: 92005F972D) PEG-75 LANOLIN (UNII: 09179OX7TB) TRIDECYL ALCOHOL (UNII: 8I9428H868) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-0039-03 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 11/21/2022 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-0039)