Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution
- NDC Code(s): 0116-1061-04
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 14, 2023
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- 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
- healhcare personnel handwash: helps reduce bacteria that potentially can cause disease
- patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
- skin wound and general skin cleansing
- Warnings
- Do not use
-
When using this product
- keep out of the eyes, ears and mouth. May cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated ear drums.
- if solution should contact these areas, rinse our 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 ecept when advised be a health care provider
- Stop use and ask a doctor if
- Keep out of reach of children
-
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 amd interdigital spaces
- a seprate 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?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-1061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) GLUCONOLACTONE (UNII: WQ29KQ9POT) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) PEG-75 LANOLIN (UNII: 09179OX7TB) WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) TRIDECYL ALCOHOL (UNII: 8I9428H868) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-1061-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 08/31/2011 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-1061)