FDA Label for Scrub-stat
View Indications, Usage & Precautions
Scrub-stat Product Label
The following document was submitted to the FDA by the labeler of this product Ecolab Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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
- 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
- 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
- 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
Surgical hand scrub
Healthcare personnel handwash
Skin wound and general skin cleanser
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
Otc - 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, Healthcare Personnel Handwash, and Skin Wound and General Skin Cleanser
Net Contents:
25 fl oz (750 mL)
6000155
KEEP FROM FREEZING
WARNING! This product contains a chemical known to the
State of California to cause cancer
Ecolab · 370 Wabasha Street N · St Paul MN 55102-1390 USA
© 2015 Ecolab USA Inc · All rights reserved
Made in United States
www.ecolab.com · 759972/8501/0715
* Please review the disclaimer below.