Label: SCRUB CARE EXIDINE -4 CHG- chlorhexidine gluconate liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 0116-2994-05 - Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 21, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purposes
-
Uses
- surgical hand scrub: significantly reduces the number of microorganisms on the hand and forearms prior to surgery or patient care
- healthcare personnel hand wash: 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
- 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 thus product
- in contact with meninges
- in 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 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 if 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
-
Direction
- 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 arms 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 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
- dry with a sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin wound and general skin cleansing:
- 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
NDC 0116-2994
BD Scrub Care™
Exidine™ - 4 CHG 4%
Chlorhexidine Gluconate 4% Solution
Antiseptic
Non-sterile Solution
Contains:
4% Chlorhexidine Gluconate
For External Use Only
For Single Use Only
Distributed By
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10081 Rev. A
ETOBTLLBLE
Net Contents: 4 fl oz (118 mL)
-
INGREDIENTS AND APPEARANCE
SCRUB CARE EXIDINE -4 CHG
chlorhexidine gluconate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-2994 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCO DIETHANOLAMIDE (UNII: 92005F972D) GLUCONOLACTONE (UNII: WQ29KQ9POT) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) TRIDECYL ALCOHOL (UNII: 8I9428H868) PEG-75 LANOLIN (UNII: 09179OX7TB) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-2994-05 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/11/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 11/01/2012 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-2994)