Label: SCRUB CARE EXIDINE -4 CHG- chlorhexidine gluconate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0116-2994-01, 0116-2994-04, 0116-2994-08, 0116-2994-16, view more0116-2994-17, 0116-2994-32, 0116-2994-33 - 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 Ingredients
- 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 preoperatve skin preparation: for the preparation of the patient's skin prior to surgery
skin wound and general skin 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
- 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 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 advised by a health care provider
- Stop use and ask a doctor if
- Keep out of reach of children.
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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 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 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 and principal display panel
NDC 0116-2994-04
REF 29900-404
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate 4% Solution
Antiseptic
Non-sterile Solution
Contans:
4% Chlorhexidine Gluconate
For External Use Only
For Single Use Only
Distributed By
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10096 Rev. A
4CFB04BTLBLE
Net Contents: 4 fl oz (118 mL)
NDC 0116-2994-05
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate 4% Solution
Antiseptic
Non-sterile Solution
Contains:
4% Chlorhxidine 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)
NDC 0116-2994-08
REF 29900-408
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate
4% Solution
Antiseptic
Contains: 4% Chlorhexidine Gluconate
For External Use Only
Distributed by
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10097 Rev. A
4CF08BTLBLE
Net Contents: 8 fl oz (237 mL)
NDC 0116-2994-16
REF 29900-416
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate
4% Solution
Antiseptic
Contains:
4% Chlorhexidine Gluconate
For External Use Only
Distributed By
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10098 Rev. A
4CFB16BTLLBLC
Net Contents: 16 fl oz (1 pt) (473 mL)
NDC 0116-2994-17
REF 29900-416P
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate
4% Solution
Antiseptic
Contains:
4% Chlorhexidine Gluconate
For External Use Only
Distributed By
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10099 Rev. A
4CFB16BTLPLBLC
Net Contents: 16 fl oz (1 pt) (473 mL)
NDC 0116-2994-32
REF 29900-432
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate
4% Solution
Antiseptic
Contains: 4% Chlorhexidine Gluconate
For External Use Only
Distributed by
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10100 Rev. A
4CFB32BTLLBLC
Net Contents: 32 fl oz (1 qt) (946 mL)
NDC 0116-2994-33
REF 29900-432P
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate
4% Solution
Antiseptic
Contains: 4% Chlorhexidine Gluconate
For External Use Only
Distributed by
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10101 Rev. A
4CF32BTLPLBLC
Net Contents: 32 fl oz (1 qt) (946 mL)
NDC 0116-2994-01
REF 29900-401
BD Scrub Care™
Exidine™-4 CHG 4%
Chlorhexidine Gluconate
4% Solution
Antiseptic
Contains:
4% Chlorhexidine Gluconate
For External Use Only
Distributed by
Becton, Dickinson and Company
Vernon Hills, IL 60061 USA
51-10095 Rev. A
4CF1GBTLLBLD
Net Contents: 128 fl oz (1 gal) (3.8 L)
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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) PEG-75 LANOLIN (UNII: 09179OX7TB) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) GLUCONOLACTONE (UNII: WQ29KQ9POT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-2994-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2012 2 NDC:0116-2994-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2012 3 NDC:0116-2994-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2012 4 NDC:0116-2994-17 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2012 5 NDC:0116-2994-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2012 6 NDC:0116-2994-33 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2012 7 NDC:0116-2994-01 3786 mL in 1 JUG; Type 0: Not a Combination Product 11/01/2012 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)