994 Chg Foaming Hand Wash

994 Chg Foaming Hand Wash
SPL v5
SPL
SPL Set ID 9b926809-65e9-4e5b-e053-2995a90add10
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2020-01-01

Description

Chlorhexidine gluconate 2% solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 2% solution

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
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.

Surgical hand scrub:

  • • wet hands and forearms with water
  • • scrub for 3 minutes with 5 mL of product (7 strokes) and a wet brush, paying close attention to the nails, cuticles and skin between the fingers
  • • a separate nail cleaner may be used
  • • rinse thoroughly
  • • wash for an additional 3 minutes with 5 mL of product (7 strokes) and rinse under running water and dry thoroughly

Healthcare personnel handwash:

  • • wet hands with water
  • • dispense 5 mL of product (7 strokes) into cupped hands and wash in a vigorous manner for 15 seconds
  • • rinse and dry thoroughly
Do Not Use

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

Package Label

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

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
Manufacturing Information

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

REF: HHCHG1000FM

V4 RL23XLI

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
  • • 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
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.

Surgical hand scrub:

  • • wet hands and forearms with water
  • • scrub for 3 minutes with 5 mL of product (7 strokes) and a wet brush, paying close attention to the nails, cuticles and skin between the fingers
  • • a separate nail cleaner may be used
  • • rinse thoroughly
  • • wash for an additional 3 minutes with 5 mL of product (7 strokes) and rinse under running water and dry thoroughly

Healthcare personnel handwash:

  • • wet hands with water
  • • dispense 5 mL of product (7 strokes) into cupped hands and wash in a vigorous manner for 15 seconds
  • • rinse and dry thoroughly
Do Not Use (Do not use)

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

Package Label

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

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
Manufacturing Information

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

REF: HHCHG1000FM

V4 RL23XLI

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.


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