SPL v2
SPL
SPL Set ID 365c3ac6-6c1f-594b-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (20 mg)
Inactive Ingredients
Citric Acid Monohydrate Coco Diethanolamide Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Isopropyl Alcohol Lauramine Oxide Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2016-05-01

Description

Drug Facts

Purpose

surgical hand scrub healthcare personnel handwash


Medication Information

Purpose

surgical hand scrub

healthcare personnel handwash

Description

Drug Facts

Uses
  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 51945-4

NDC 21749-850-53

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Gojo Industries, Inc.

Akron, OH 60085 USA

330-255-6000

www.gojo.com

GOJO18BTLLBL

Gojo ® 2018

Net Wt 18 fl oz (535 mL)

Warnings

For external use only

Directions
  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Do Not Use
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this product
Active Ingredient

chlorhexidine gluconate 2% solution

Other Information
  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)
​allergy Alert:

This product may cause a serious 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.

Inactive Ingredients

citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

call 1-800-321-9647 Monday through Friday 8 AM to 5 PM MST

Surgical Hand Scrub:
  • wet hands and forearms with water
  • scrub for 3 minutes with 5 ml of solution and a wet brush paying close attention to the nails, cuticles, and interdigital space
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of solution and rinse under running water
  • dry thoroughly
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 eardrums
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • Do not use routinely if you have wounds which involve more than the superficial layers of the skin
Healthcare Personnel Handwash:
  • wet hands with water
  • dispense 5 ml of solution (4 full strokes) into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
  • dry thoroughly

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: helps reduce bacteria that potentially can cause disease
Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

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

Section 51945-4 (51945-4)

NDC 21749-850-53

Chlorhexidine Gluconate 2% Solution

Antiseptic Foam Handwash

Distributed by:

Gojo Industries, Inc.

Akron, OH 60085 USA

330-255-6000

www.gojo.com

GOJO18BTLLBL

Gojo ® 2018

Net Wt 18 fl oz (535 mL)

Purpose

surgical hand scrub

healthcare personnel handwash

Warnings

For external use only

Directions
  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Do Not Use (Do not use)
  • if you are allergic to chlorhexidine gluconate or any other ingredient in this product
Active Ingredient (Active ingredient)

chlorhexidine gluconate 2% solution

Other Information (Other information)
  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)
​allergy Alert: (​Allergy alert:)

This product may cause a serious 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.

Inactive Ingredients (Inactive ingredients)

citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

call 1-800-321-9647 Monday through Friday 8 AM to 5 PM MST

Surgical Hand Scrub: (Surgical hand scrub:)
  • wet hands and forearms with water
  • scrub for 3 minutes with 5 ml of solution and a wet brush paying close attention to the nails, cuticles, and interdigital space
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of solution and rinse under running water
  • dry thoroughly
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 eardrums
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • Do not use routinely if you have wounds which involve more than the superficial layers of the skin
Healthcare Personnel Handwash: (Healthcare personnel handwash:)
  • wet hands with water
  • dispense 5 ml of solution (4 full strokes) into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
  • dry thoroughly

Advanced Ingredient Data


Raw Label Data

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