Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID b4444803-034c-4e22-9a21-9e07207df36e
Route
TOPICAL
Published
Effective Date 2024-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (40 mg)
Inactive Ingredients
Coco Diethanolamide Cocamine Oxide Gluconic Acid Gluconolactone Hydroxyethyl Cellulose (3000 Cps At 1%) Isopropyl Alcohol Peg-75 Lanolin Peg-150 Distearate Propylene Glycol Quaternium-33 Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1986-07-22 Until 2024-10-15

Description

Chlorhexidine gluconate solution, 4%

Purpose

Surgical hand scrub Healthcare personnel handwash


Medication Information

Purpose

Surgical hand scrub

Healthcare personnel handwash

Description

Chlorhexidine gluconate solution, 4%

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
Section 50565-1

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

Section 50569-3

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Section 51727-6

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

Section 53413-1

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

Warnings

For external use only

Allergy alert:

This product may cause a sever allergic reaction.

Symptoms may include:

  • wheezing/difficulty breathing 
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help 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
Do Not Use
  • if you are allergic to chlorhexidine gluconate or any other ingredients in this product
Active Ingredient

Chlorhexidine gluconate solution, 4%

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)
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 inolve more than the superficial layers of the skin
Representative Label and Principal Display Panel

ECOLAB®

NDC 47596-464-32

SCRUB-STAT 4%

Chorhexidine Gluconate

4% Solution Antiseptic

Surgical Hand Scrub and

Healthcare Personnel Handwash

6030447 Hand Pump

6030450 Foot Pump

Net Content: 33.8 fl oz (1000 mL)

KEEP FROM FREEZING

Ecolab • 1 Ecolab Place • St Paul MN 55102 USA

© 2018 Ecolab USA Inc • All rights reserved

Made in United States • 762529/8501/0218


Structured Label Content

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
Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

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

Purpose

Surgical hand scrub

Healthcare personnel handwash

Warnings

For external use only

Allergy alert:

This product may cause a sever allergic reaction.

Symptoms may include:

  • wheezing/difficulty breathing 
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help 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
Do Not Use (Do not use)
  • if you are allergic to chlorhexidine gluconate or any other ingredients in this product
Active Ingredient (Active ingredient)

Chlorhexidine gluconate solution, 4%

Other Information (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)
When Using 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 inolve more than the superficial layers of the skin
Representative Label and Principal Display Panel (Representative label and principal display panel)

ECOLAB®

NDC 47596-464-32

SCRUB-STAT 4%

Chorhexidine Gluconate

4% Solution Antiseptic

Surgical Hand Scrub and

Healthcare Personnel Handwash

6030447 Hand Pump

6030450 Foot Pump

Net Content: 33.8 fl oz (1000 mL)

KEEP FROM FREEZING

Ecolab • 1 Ecolab Place • St Paul MN 55102 USA

© 2018 Ecolab USA Inc • All rights reserved

Made in United States • 762529/8501/0218


Advanced Ingredient Data


Raw Label Data

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