Label: CHLORHEXIDINE GLUCONATE- antiseptic skin cleanser gel
- NDC Code(s): 68599-5400-1, 68599-5400-2, 68599-5400-3
- Packager: McKesson
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 12, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
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:for the preparation of the patient's skin prior to surgery skin wound and general skin cleansing
- Skin wound and general skin cleansing
-
WARNINGS
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
WARNING: This product can expose you
to coconut oil diethanolamine
condensate (cocamide diethanolamine),
which is known to the State of California
to cause cancer. For more information
go to www.P65Warnings.ca.gov. -
STOP USE
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use- if you are allergic to chlorhexidine gluconate or any other ingredients 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 the underlying
condition makes it necessary to reduce the bacterial population of the skin
Stop use and ask doctor ifirritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. - KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- use with care in premature infants or infants under 2 months of age. These products may causeirritation or chemical burns.
Surgical hand s crub:
- 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 SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHLORHEXIDINE GLUCONATE
antiseptic skin cleanser gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-5400 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) PEG-75 LANOLIN (UNII: 09179OX7TB) GLUCONOLACTONE (UNII: WQ29KQ9POT) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) TRIDECYL ALCOHOL (UNII: 8I9428H868) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-5400-3 10 in 1 CASE 03/12/2018 1 NDC:68599-5400-2 50 in 1 BOX 1 NDC:68599-5400-1 15 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 03/12/2018 Labeler - McKesson (023904428) Establishment Name Address ID/FEI Business Operations XTTRIUM LABORATORIES, INC. 007470579 manufacture(68599-5400)