Label: BACTOSHIELD CHG- chlorhexidine gluconate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 0116-1344-03, 0116-1344-08, 0116-1344-24, 0116-1344-34 - Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 6, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purposes
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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
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Warnings
For external use only
Allergy alert:
This product may cause a sever 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 deadness when instilled in the middle ear through perforated eardrums.
- if solution should contact these areas, rinse out prompty 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
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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
- Other information
- Inactive ingredients
- Questions or comments?
- OTHER SAFETY INFORMATION
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PRINCIPAL DISPLAY PANEL
Bactoshield ® CHG 4%
NDC 11084-815-03
Surgical Scrub
Chlorhexidine Cluconate 4% Solution Antiseptic
Non-sterile Solution
Surgical Scrub
4% CHG
Antimicrobial
For Single-Use
Net Contents: 118 mL (4 fl oz)
REORDER #1344-39
1344-52F(319)
61346
4BACT04BTLLBLD
Bactoshield ® CHG 4%
NDC 11084-815-34
Surgical Scrub
Chlorhexidine Gluconate 4% Solution Antiseptic
Surgical Scrub
4% CHG
Antimicrobial
Net Contents: 473mL (16 fl oz) (1 pt)
REORDER #1344-33
61340
1344-31H(319)
4BACT16BTLLBLE
Bactoshield ® CHG 4%
NDC 11084-815-24
Surgical Scrub
4% Solution Antiseptic Chlorhexidine Gluconate
Surgical Scrub
4% CHG
Antimicrobial
Net Contents: 32 fl oz (946 mL)
REORDER #1344-24
61341
1344-21H(319)
4BACT32BTLLBLB
Bactoshield ® CHG 4%
NDC 11084-815-08
Surgical Scrub
Chlorhexidine Gluconate 4% Solution Antiseptic
Surgical Scrub
4% CHG
Antimicrobial
Net Contents: 128 fl oz (1 Gal) (3.78 Liters)
REORDER #1344-08
1344-06G(319)
51690
4BACT1GLBLB
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INGREDIENTS AND APPEARANCE
BACTOSHIELD CHG
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-1344 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) PEG-75 LANOLIN (UNII: 09179OX7TB) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-1344-08 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/04/1999 2 NDC:0116-1344-24 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/04/1999 3 NDC:0116-1344-34 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/04/1999 4 NDC:0116-1344-03 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/04/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 10/04/1999 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-1344)