2% Gojo Adx/ltx

2% Gojo Adx/ltx
SPL v6
SPL
SPL Set ID 46dd136c-d569-0450-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-07-01
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 2016-07-01

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 43683-2

Indications and Usage

Dosage and Administration

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

PROVON® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOADXFLBLC

8842-643-F

8842

NDC 21749-850-90

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

42 fl oz (1250 mL)

GOJOADXBLBLB

8842-642-B

PROVON ® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOLTXFLBLC

1922-643-F

.

1922

NDC 21749-850-89

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

40.5 fl oz (1200 mL)

GOJOLTXBLBLB

1922-642-B

Warnings

For external use only

Allergy alert:

This product may cause a severe 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 products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with 5 mL of product (6 full stokes), 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 (6 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

Other Information
  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)
Inactive Ingredients

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

Questions Or Comments?

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

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

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 43683-2 (43683-2)

Indications and Usage

Dosage and Administration

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)

PROVON® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOADXFLBLC

8842-643-F

8842

NDC 21749-850-90

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

42 fl oz (1250 mL)

GOJOADXBLBLB

8842-642-B

PROVON ® Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2% Solution - Antiseptic

GOJOLTXFLBLC

1922-643-F

.

1922

NDC 21749-850-89

Brought to you by GOJO

PROVON ®

Antimicrobial Foam Handwash with 2% CHG

Chlorhexidine Gluconate 2% Solution - Antiseptic

40.5 fl oz (1200 mL)

GOJOLTXBLBLB

1922-642-B

Purpose

Antiseptic

Warnings

For external use only

Allergy alert:

This product may cause a severe 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 products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with 5 mL of product (6 full stokes), 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 (6 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

Other Information (Other information)
  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

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

Advanced Ingredient Data


Raw Label Data

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