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NDC 00116-2992-01 Scrub Care 2 g/100mL Details
Scrub Care 2 g/100mL
Scrub Care is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is CHLORHEXIDINE GLUCONATE.
Product Information
| NDC | 00116-2992 |
|---|---|
| Product ID | 0116-2992_a7bd3755-1162-97f3-e053-2995a90a1f21 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Scrub Care |
| Proprietary Name Suffix | Exidine-2 CHG |
| Non-Proprietary Name | CHLORHEXIDINE GLUCONATE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | g/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 | NDA019422 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 00116-2992-01 (00116299201)
| NDC Package Code | 0116-2992-01 |
|---|---|
| Billing NDC | 00116299201 |
| Package | 3786 mL in 1 JUG (0116-2992-01) |
| Marketing Start Date | 2010-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9237363e-e648-4d69-a003-232051832024 Details
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
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 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
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
Inactive ingredients
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)
INGREDIENTS AND APPEARANCE
| SCRUB CARE
EXIDINE-2 CHG
chlorhexidine gluconate solution |
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| Labeler - Xttrium Laboratories, Inc. (007470579) |
| Registrant - Xttrium Laboratories, Inc. (007470579) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Xttirum Laboratories, Inc. | 007470579 | manufacture(0116-2992) | |