ENDURE 400 SCRUB-STAT 4- chlorhexidine gluconate solution

Endure 400 Scrub-Stat 4 by

Drug Labeling and Warnings

Endure 400 Scrub-Stat 4 by is a Otc medication manufactured, distributed, or labeled by Ecolab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chlorhexidine gluconate, 4%

Purposes

Surgical hand scrub

Healthcare personnel handwash

Skin wound and general skin cleanser

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

Stop use and ask a doctor if

• irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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

• store between 20-25°C (68-77°F)
• avoid excessive heat (above 104°F/40°C)
• For additional information, see Material Safety Data Sheet (MSDS)
• For emergency medical information in USA and Canada, call 1-800-328-0026
• For emergency medical information worldwide, call 1-651-222-5352 (in the USA)

INACTIVE INGREDIENT

Inactive ingredients cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water
*contains one or more of these ingredients

QUESTIONS

Questions? call 1.866.781.8787, 24 hours a day, 7 days a week

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47593-265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMINE OXIDE (UNII: QWA2IZI6FI)
GLUCONIC ACID (UNII: R4R8J0Q44B)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG-75 LANOLIN (UNII: 09179OX7TB)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
QUATERNIUM-33 (UNII: XPS4174QZJ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47593-265-36	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019258	10/01/2006

Labeler - Ecolab Inc. (006154611)