Label: SCRUB CARE EXIDINE-2 CHG- chlorhexidine gluconate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 0116-2992-01, 0116-2992-04, 0116-2992-08, 0116-2992-16, view more0116-2992-17, 0116-2992-32, 0116-2992-33 - Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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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 cleansing
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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
rashIf 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 if permitted to enter and remain in the eye of 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 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 under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
- scrub for 1.5 minutes with about 8 ml of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
- rinse thoroughly under running water for 30 seconds
- wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
- 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 about 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 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?
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Package Label
NDC 0116-2992-04
REF 29900-204
BD Scrub Care™
Exidine™-2 CHG 2%
Chlorhexidine Gluconate 2% Solution
Antiseptic
Non-sterile Solution
Contains:
2% Chlorhexidine Gluconate
For External Use Only
For Single Use Only
Distributed By
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10089 Rev. A
2CFB04BTLBLE
Net Contents: 4 fl oz (118 mL)
NDC 0116-2992-08
REF 29900-208
BD Scrub Care™
Exidine™-2 CHG 2%
Chlorhexidine Gluconate
2% Solution
Antiseptic
Contains: 2% Chlorhexidine Gluconate
For External Use Only
Distributed by
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10090 Rev. A
2CF08BTLBLE
Net Contents: 8 fl oz (237 mL)
NDC 0116-2992-16
REF 29900-216
BD Scrub Care™
Exidine™-2 CHG 2%
Chlorhexidine Gluconate
2% Solution
Antiseptic
Contains:
2% Chlorhxidine Gluconate
For External Use Only
Distributed By
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10091 Rev. A
2CFB16BTLLBLC
Net Contents: 16 fl oz (1 pt) (473 mL)
NDC 0116-2992-17
REF 29900-216P
BD Scrub Care™
Exidine™-2 CHG 2%
Chlorhexidine Gluconate
2% Solution
Antiseptic
Contains:
2% Chlorhexidine Gluconate
For External Use Only
Distributed By
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10092 Rev. A
2CFB16BTLPLBLC
Net Contents: 16 fl oz (1 pt) (473 mL)
NDC 0116-2992-32
REF 29900-232
BD Scrub Care™
Exidine™-2 CHG 2%
Chlorhexidine Gluconate
2% Solution
Antiseptic
Contains: 2% Chlorhexidine Gluconate
For External Use Only
NDC 0116-2992-33
REF 29900-232P
BD Scub Care™
Exidine™-2 CHG 2%
Chlorhexidine Gluconate
2% Solution
Antiseptic
Contains: 2% Chlorhexidine Gluconate
For External Use Only
Distributed by
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10094 Rev. A
2CFB32BTLPLBLC
Net Contents: 32 fl oz (1 qt) (946 mL)
NDC 0116-2992-01
REF 29900-201
BD Scrub Care™
Exidine™-2 CHG 2%
Chlorhexidine Gluconate
2% Solution
Antiseptic
Contains:
2% Chlorhexidine Gluconate
For External Use Only
Distributed by
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10088 Rev. A
2CFB1GBTLLBLD
Net Contents: 128 fl oz (1 gal) (3.8 L)
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INGREDIENTS AND APPEARANCE
SCRUB CARE EXIDINE-2 CHG
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-2992 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength LAURAMINE OXIDE (UNII: 4F6FC4MI8W) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-2992-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2010 2 NDC:0116-2992-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2010 3 NDC:0116-2992-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2010 4 NDC:0116-2992-17 473 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/01/2010 5 NDC:0116-2992-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2010 6 NDC:0116-2992-33 946 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/01/2010 7 NDC:0116-2992-01 3786 mL in 1 JUG; Type 0: Not a Combination Product 05/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 05/01/2010 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttirum Laboratories, Inc. 007470579 manufacture(0116-2992)