Label: BACTOSHIELD CHG CHLORHEXIDINE GLUCONATE SOLUTION- chlorhexidine gluconate solution
- NDC Code(s): 11084-815-03, 11084-815-08, 11084-815-24, 11084-815-34
- Packager: Deb USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated April 4, 2018
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only
This product may cause a severe allergic reaction.
Symptoms may include:
- wheezing/difficulty breathing
- facial swelling
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
When using this product
- keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
- 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?
- PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
INGREDIENTS AND APPEARANCE
BACTOSHIELD CHG CHLORHEXIDINE GLUCONATE SOLUTION
chlorhexidine gluconate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11084-815 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:11084-815-08 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 2 NDC:11084-815-24 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 3 NDC:11084-815-34 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 4 NDC:11084-815-03 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 02/01/2018 Labeler - Deb USA, Inc. (607378015) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 MANUFACTURE(11084-815)