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NDC 47593-0265-36 Endure 400 Scrub-Stat 4 40 mg/mL Details
Endure 400 Scrub-Stat 4 40 mg/mL
Endure 400 Scrub-Stat 4 is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Ecolab Inc.. The primary component is CHLORHEXIDINE GLUCONATE.
Product Information
| NDC | 47593-0265 |
|---|---|
| Product ID | 47593-265_d2aad5a2-0e50-4e30-a17a-2211db809052 |
| 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 | Endure 400 Scrub-Stat 4 |
| 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 | mg/mL |
| Substance Name | CHLORHEXIDINE GLUCONATE |
| Labeler Name | Ecolab Inc. |
| Pharmaceutical Class | Decreased Cell Wall Integrity [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019258 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 47593-0265-36 (47593026536)
| NDC Package Code | 47593-265-36 |
|---|---|
| Billing NDC | 47593026536 |
| Package | 800 mL in 1 BOTTLE, PLASTIC (47593-265-36) |
| Marketing Start Date | 2006-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL be4c56c9-10c4-4921-8a9c-64f2a5a66d0e 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: handwash to help reduce bacteria that potentially can cause disease
- skin wound and general skin cleanser: helps reduce bacteria on the skin
Warnings
For external use only
Do not use
- if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
- as a patient preoperative skin preparation (especially on the head or face)
- in contact with meninges
- in the genital area
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 ear drums.
- if contact occurs, rinse with cold water right away
- 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 underlying condition makes it necessary to reduce the bacterial population of the skin
Directions
- use full strength
- do not dilute
Surgical hand scrub
- remove jewelry
- wet hands and forearms with water and dispense 5 grams (70 mL of foam) of product into hands
- wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
- rinse thoroughly with water
- wash for an additional 3 minutes with 5 grams (70 mL of foam) of product into hands and rinse under running water
- dry thoroughly
Healthcare personnel handwash
- wet hands with water
- dispense about 5 grams (70 mL of foam) of product into hands and wash in a vigorous manner for 30 seconds
- rinse and dry thoroughly
Skin wound and general skin cleanser
- thoroughly rinse the area to be cleansed with water
- apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
- rinse again thoroughly
Other information
SPL UNCLASSIFIED SECTION
Representative label and principal display panel
Huntington brand®
NDC 47593-265-36
DIN 02239252
ENDURE® 4%
Chlorhexidine gluconate solution, 4%
Foam Forming Solution
Surgical Hand Scrub • Healthcare Personnel Hand Wash
Skin Synergy™
Dermatology Management System
Ecolab®
Net Contents: 27 fl oz/800 mL
Ecolab Healthcare Division
370 Wabasha Street N., St. Paul, MN 55102
5105 Tomken Road, Mississauga,
Ont. Canada L4W 2X5
© 2006 Ecolab Inc. 706169/8502/0206
All Rights Reserved
Made in U.S.A.
Reorder #61430436
INGREDIENTS AND APPEARANCE
| ENDURE 400 SCRUB-STAT 4
chlorhexidine gluconate solution |
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| Labeler - Ecolab Inc. (006154611) |
Revised: 4/2018
Document Id: d2aad5a2-0e50-4e30-a17a-2211db809052
Set id: be4c56c9-10c4-4921-8a9c-64f2a5a66d0e
Version: 2
Effective Time: 20180427