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NDC 00116-2994-05 Scrub Care 4 mg/100mL Details

Scrub Care 4 mg/100mL

Scrub Care is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is CHLORHEXIDINE GLUCONATE.

Product Information

NDC	00116-2994
Product ID	0116-2994_b2305626-fff1-610d-e053-2995a90a93bf
Associated GPIs
GCN Sequence Number	007254
GCN Sequence Number Description	chlorhexidine gluconate LIQUID 4 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	30011
HICL Sequence Number	004297
HICL Sequence Number Description	CHLORHEXIDINE GLUCONATE
Brand/Generic	Brand
Proprietary Name	Scrub Care
Proprietary Name Suffix	Exidine -4 CHG
Non-Proprietary Name	Chlorhexidine gluconate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	mg/100mL
Substance Name	CHLORHEXIDINE GLUCONATE
Labeler Name	Xttrium Laboratories, Inc.
Pharmaceutical Class	Decreased Cell Wall Integrity [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019125
Listing Certified Through	2022-12-31

Package

Package Images

NDC 00116-2994-05 (00116299405)

Pricing Information	N/A
NDC Package Code	0116-2994-05
Billing NDC	00116299405
Package	118 mL in 1 BOTTLE, PLASTIC (0116-2994-05)
Marketing Start Date	2012-11-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d28b205d-e3af-488e-86e9-caa766998390 Details

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purposes

Antiseptic

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

Stop use and ask doctor

If irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Store at 20-25º C (68-77ºF)
Avoid excessive heat above 40ºC (104ºF)

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

Call 1-800-587-3721

Monday through Friday 8:00 AM to 4:30 PM CST

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 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0116-2994
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0116-2994-05	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019125	11/01/2012

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Name	Address	ID/FEI	Business Operations
Establishment
Xttrium Laboratories, Inc.		007470579	manufacture(0116-2994)

Revised: 10/2020

Document Id: b2305626-fff1-610d-e053-2995a90a93bf

Set id: d28b205d-e3af-488e-86e9-caa766998390

Version: 5

Effective Time: 20201021