SCRUB-STAT- chlorhexidine gluconate solution

Scrub-Stat by

Drug Labeling and Warnings

Scrub-Stat 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 solution, 4%

Purposes

Surgical hand scrub

Healthcare personnel handwash

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

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 hellp right away

Do not use

• if you are allergic to chlorhexidine gluconate or any other ingredients in this product

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 ear drums.
• if contact occurs, rinse with cold water right away
• do not use routinely if you have wounds which involve more than the superficial layers of the skin

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. 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 with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
• use full strength
• do not dilute

Surgical hand scrub

• remove jewelry
• wet hands and forearms with water and dispense 10 pumps (5 grams) 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 10 pumps (5 grams) of product into hands and rinse under running water
• dry thoroughly

Healthcare personnel handwash

• wet hands with water
• dispense 10 pumps (5 grams) of product into hands and wash in a vigorous manner for 30 seconds
• rinse and dry thoroughly

Other information

• store between 20-25°C (68-77°F)
• avoid excessive heat (above 104°F/40°C)
• for additional information, see Safety Data Sheet (SDS)
• 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*, 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

ECOLAB®

NDC: 47593-468-41

SCRUB-STAT™ 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic Foam Forming Solution

Surgical Hand Scrub and Healthcare Personnel Handwash

Net Contents:

25 fl oz (750 mL)

6000155

KEEP FROM FREEZING

WARNING!

This product can expose you to chemicals including amides, coco, n,n-bis(hydroxyethyl) and 2,2’-iminodiethanol which are known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

Ecolab · 1 Ecolab Place · St Paul MN 55102 USA

© 2018 Ecolab USA Inc · All rights reserved

Made in United States

www.ecolab.com · 759972/8504/0718

INGREDIENTS AND APPEARANCE

SCRUB-STAT 
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47593-468
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: 47593-468-41	750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/03/2011
2	NDC: 47593-468-59	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/03/2011
3	NDC: 47593-468-44	1134000 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/22/2015
4	NDC: 47593-468-21	208000 mL in 1 DRUM; Type 0: Not a Combination Product	06/04/2013
5	NDC: 47593-468-36	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019258	03/03/2011

Labeler - Ecolab Inc. (006154611)