Scrub-stat Solution
FDA Label NDC 47593-467

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ecolab Inc. for the product Scrub-stat (NDC 47593-467). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purposes, uses, warnings, do not use, when using this product, otc - ask doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Chlorhexidine gluconate, 2%

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

Otc - Ask Doctor

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 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 9 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 9 pumps (5 grams) of product into hands and rinse under running water
    • dry thoroughly
    • Healthcare personnel handwash

      • wet hands with water
      • dispense 9 pumps (5 grams) 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 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 47593-467-41

SCRUB-STAT™ 2%

Chlorhexidine Gluconate 2% 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)

6000067

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 · 759968/8501/0715

Representative Label (Label)

Representative Label (Label)

* Please review the disclaimer below.