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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 |
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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)
NDC Package Code | 0116-2994-05 |
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Billing NDC | 00116299405 |
Package | 118 mL in 1 BOTTLE, PLASTIC (0116-2994-05) |
Marketing Start Date | 2012-11-11 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d28b205d-e3af-488e-86e9-caa766998390 Details
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
Inactive Ingredients
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 |
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Labeler - Xttrium Laboratories, Inc. (007470579) |
Registrant - Xttrium Laboratories, Inc. (007470579) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Xttrium Laboratories, Inc. | 007470579 | manufacture(0116-2994) |