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NDC 00116-0505-01 BD E-Z Scrub 40 g/1000mL Details
BD E-Z Scrub 40 g/1000mL
BD E-Z Scrub 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 | 00116-0505 |
|---|---|
| Product ID | 0116-0505_b17e4edc-c82c-85a7-e053-2995a90a8e36 |
| 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 | BD E-Z Scrub |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | chlorhexidine gluconate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | g/1000mL |
| 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 | NDA019127 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00116-0505-01 (00116050501)
| NDC Package Code | 0116-0505-01 |
|---|---|
| Billing NDC | 00116050501 |
| Package | 946 mL in 1 BOTTLE (0116-0505-01) |
| Marketing Start Date | 2006-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4a62ea05-32de-683e-e054-00144ff8d46c Details
Uses
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.
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
- do not use routinely if you have wounds which involve more than the superficial layers of the skin
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 2.0 cubic inches 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 2.0 cubic inches of product and rinse under running water
- dry thoroughly
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
NDC 17271-505-02
BD E-Z Scrub
Chlorhexidine Gluconate 4% Solution Antiseptic
REF 372412
Foreign Patents and Patents Pending
U.S. Patent 6,427,875
CHLORHEXIDINE GLUCONATE
32 fl oz (946 mL)
NDC 17271-505-01
BD E-Z Scrub
Chlorhexidine Gluconate 4% Solution Antiseptic
REF 372402
Foreign Patents and Patents Pending
U.S. Patents 6,053,369 6,308,866
Chlorhexidine Gluconate
32 fl oz (946 ml)
INGREDIENTS AND APPEARANCE
| BD E-Z SCRUB
chlorhexidine gluconate solution |
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| Labeler - Xttrium Laboratories, Inc. (007470579) |
| Registrant - Xttrium Laboratories, Inc. (007470579) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Xttrium Laboratories, Inc. | 007470579 | manufacture(0116-0505) | |
Revised: 10/2020
Document Id: b17e4edc-c82c-85a7-e053-2995a90a8e36
Set id: 4a62ea05-32de-683e-e054-00144ff8d46c
Version: 5
Effective Time: 20201012