Hibiclens Ifp

Hibiclens Ifp
SPL v14
SPL
SPL Set ID 29b547bf-c08e-14c2-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2018-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Gluconolactone Lauramine Oxide Water Fd&c Red No. 40 Isopropyl Alcohol Poloxamer 237

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
NDA Active Since 2016-02-15

Description

Chlorhexidine gluconate solution 4.0% w/v


Medication Information

Description

Chlorhexidine gluconate solution 4.0% w/v

Uses
  • antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease
  • for skin wound and general skin cleansing
  • surgical hand scrub
  • healthcare personnel handwash
Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Chlorhexidine gluconate solution 4.0% w/v

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.
  • skin wound and general skin cleansing.

Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly.

  • surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL (4 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
  • healthcare personnel handwash.

Wet hands with water. Dispense about 5 mL (4 pumps) of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Do Not Use
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with the meninges
  • in the genital area
Questions?

1-800-843-8497

Allergy Alert:

This product may cuase 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.

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

fragrance, gluconolactone, isopropyl alcohol 4% w/v, lauramine oxide, poloxamer 237, purified water and red 40

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 contact occurs in any of these areas, rinse with cold water right away
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general cleansing of large body areas should not be done except when advised by a health care provider
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
  • antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease
  • for skin wound and general skin cleansing
  • surgical hand scrub
  • healthcare personnel handwash
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Chlorhexidine gluconate solution 4.0% w/v

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.
  • skin wound and general skin cleansing.

Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly.

  • surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL (4 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
  • healthcare personnel handwash.

Wet hands with water. Dispense about 5 mL (4 pumps) of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Do Not Use (Do not use)
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with the meninges
  • in the genital area
Questions?

1-800-843-8497

Allergy Alert: (Allergy alert:)

This product may cuase 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.

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

fragrance, gluconolactone, isopropyl alcohol 4% w/v, lauramine oxide, poloxamer 237, purified water and red 40

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 contact occurs in any of these areas, rinse with cold water right away
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general cleansing of large body areas should not be done except when advised by a health care provider
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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Raw Label Data

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