Scrub-stat Solution
FDA Label NDC 47593-464

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 47593-464). 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, purpose, uses, warnings, do not use, when using this product, otc - ask doctor, otc - 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, 4%

Purpose

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 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 properative 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 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.

Otc - Keep Out Of Reach Of Children

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 product may cause irritation or chemical burns.
  • use full strength
  • do not dilute
  • Surgical hand scrub

    • remove jewelry
    • wet hands and forearms with water and apply 5 mL of the product
    • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
    • rinse thoroughly with water
    • washfor an additional 3 minutes with 5 mL of the product and rinse under running water
    • dry thoroughly
    • Healthcare personnel handwash

      • wet hands with water
      • dispense about 5 mL of product into cupped 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 the 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*, hydroxyehtylcellulose, 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 47596-464-32

SCRUB-STAT™ 4%

Chorhexidine Gluconate

4% Solution Antiseptic

Surgical Hand Scrub, Healthcare Personnel Handwash,

and Skin Wound and General Skin Cleanser

6030447 Hand Pump
6030450 Foot Pump

Net Content: 33.8 fl oz (1000 mL)

WARNING! This product contains a chemical known in 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 • 762529/8500/0615

Representative Label (Label)

Representative Label (Label)

* Please review the disclaimer below.