Gojo Fmx-tfx-provon

Gojo Fmx-tfx-provon
SPL v4
SPL
SPL Set ID 759beac3-6fc8-40c6-e053-2a91aa0aab57
Route
TOPICAL
Published
Effective Date 2018-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2008-03-01

Description

Chlorhexidine gluconate 2% solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 2% solution

Uses
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
Section 51945-4

NDC 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

NDC 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

NDC 21749-106-32

PROVON BRAND

Antimicrobial Skin Cleanser

Chlorhexidine Gluconate

2% Solution

Antiseptic

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

Questions?

Tel. 800-321-9647

*330-255-6000

www.GOJO.com

©2018. All rights reserved.

2PROV32BTLLBL

4104-12

Net Contents: 32 fl oz (1qt) (946 mL)

Section 60561-8
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat about 40ºC (104ºF)
Warnings

For external use only

Allergy alert:

This product may cause a severe alleric reaction. Symptoms may include:

  • wheezing/difficulty breathting
  • 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 under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense 5 mL of product (4 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
  • dry thoroughly

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with 5 mL of product (4 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
  • a seperate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product (4 full strokes) and rinse under running water and dry thoroughly

Do Not Use

if you are allergic to chlorhexidine gluconate or any other ingredient in this product

Active Ingredient

Chlorhexidine gluconate 2% solution

Inactive Ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions Or Comments?

call 1-800-321-9647 Monday through Friday 8:30 AM to 5:00 PM

When Using This Product
  • keep out of eyes, ears and mouth. May cause serious and permenant eye injury if permitted to enter and remain in the eye or may cause deafness when instilled through 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
Stop Use and Ask A Doctor If

irritation, sensitization, or allergic reaction occurs. 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.


Structured Label Content

Uses
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
Section 51945-4 (51945-4)

NDC 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

NDC 21749-106-89

Chlorhexidine Gluconate 2% Solution

Antimicrobial SKin Cleanser

Distributed by:

Gojo Industries, Inc.

Akron, OH 44309

330-255-6000

www.gojo.com

NDC 21749-106-32

PROVON BRAND

Antimicrobial Skin Cleanser

Chlorhexidine Gluconate

2% Solution

Antiseptic

Distributed by:

GOJO Industries, Inc.

Akron, OH 44309

Questions?

Tel. 800-321-9647

*330-255-6000

www.GOJO.com

©2018. All rights reserved.

2PROV32BTLLBL

4104-12

Net Contents: 32 fl oz (1qt) (946 mL)

Section 60561-8 (60561-8)
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat about 40ºC (104ºF)
Purpose

Antiseptic

Warnings

For external use only

Allergy alert:

This product may cause a severe alleric reaction. Symptoms may include:

  • wheezing/difficulty breathting
  • 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 under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense 5 mL of product (4 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
  • dry thoroughly

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with 5 mL of product (4 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
  • a seperate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product (4 full strokes) and rinse under running water and dry thoroughly

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

Inactive Ingredients (Inactive ingredients)

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions Or Comments? (Questions or comments?)

call 1-800-321-9647 Monday through Friday 8:30 AM to 5:00 PM

When Using This Product (When using this product)
  • keep out of eyes, ears and mouth. May cause serious and permenant eye injury if permitted to enter and remain in the eye or may cause deafness when instilled through 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

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.


Advanced Ingredient Data


Raw Label Data

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