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Hibiclens

Mölnlycke Health Care US, LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic

Hibiclens 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 

For external use only

  • if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
  • as a patient preoperative skin preparation of the head or face
  • in contact with the meninges
  • in the genital area
  • on wounds that involve more than the superficial layers of skin
  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures, 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.

irritation, sensitization, or allergic reaction occurs and lasts for 72 hours.These may be signs of a serious condition.

If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 5mL of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
  • healthcare personnel handwash. Wet hands with water. Dispense about 5mL of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Questions? 1-800-843-8497

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

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

1-800-843-8497

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 0234-0575-04

HIBICLENS®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Antiseptic/Antimicrobial
Skin Cleanser

HIBICLENS® prevents skin infections thereby reducing the risk of cross-infection. HIBICLENS® has antiseptic activity and a persistent antimicrobial effect with rapid bactericidal activity against a wide range of microorganisms.

MÖLNLYCKE®
HEALTH CARE

4 Fl. oz. (118 mL)

Distributed by Mölnlycke Health Care US, LLC
Norcross, GA 30092

Hibiclens

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

NDC 0234-0575-08

HIBICLENS®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Antiseptic/Antimicrobial
Skin Cleanser

HIBICLENS® prevents skin infections thereby reducing the risk of cross-infection. HIBICLENS® has antiseptic activity and a persistent antimicrobial effect with rapid bactericidal activity against a wide range of microorganisms.

MÖLNLYCKE®
HEALTH CARE

8 Fl. oz. (236 mL)

Distributed by Mölnlycke Health Care US, LLC
Norcross, GA 30092

Hibiclens

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0234-0575-16

HIBICLENS®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Antiseptic/Antimicrobial
Skin Cleanser

HIBICLENS® prevents skin infections thereby reducing the risk of cross-infection. HIBICLENS® has antiseptic activity and a persistent antimicrobial effect with rapid bactericidal activity against a wide range of microorganisms.

MÖLNLYCKE®
HEALTH CARE

16 Fl. oz. (1 pt.) (473 mL)

Distributed by Mölnlycke Health Care US, LLC
Norcross, GA 30092

Hibiclens

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

NDC 0234-0575-32

HIBICLENS®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Antiseptic/Antimicrobial
Skin Cleanser

HIBICLENS® prevents skin infections thereby reducing the risk of cross-infection. HIBICLENS® has antiseptic activity and a persistent antimicrobial effect with rapid bactericidal activity against a wide range of microorganisms.

MÖLNLYCKE®
HEALTH CARE

32 Fl. oz. (1 qt.) (946 mL)

Distributed by Mölnlycke Health Care US, LLC
Norcross, GA 30092

Hibiclens

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

NDC 0234-0575-91

HIBICLENS®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Antiseptic/Antimicrobial
Skin Cleanser

HIBICLENS® prevents skin infections thereby reducing the risk of cross-infection. HIBICLENS® has antiseptic activity and a persistent antimicrobial effect with rapid bactericidal activity against a wide range of microorganisms.

MÖLNLYCKE®
HEALTH CARE

1 gal. (3.79 L)

Distributed by Mölnlycke Health Care US, LLC
Norcross, GA 30092

Hibiclens

Hibiclens

Chlorhexidine gluconate SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0234-0575
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
chlorhexidine gluconate CHLORHEXIDINE 213 g

Inactive Ingredients

Ingredient Name Strength
GLUCONOLACTONE
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
POLOXAMER 237
water
FD&C RED NO. 40

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 118 in 1 BOTTLE
3 236 in 1 BOTTLE
4 NDC:0234-0575-16 473 in 1 BOTTLE
5 NDC:0234-0575-32 946 in 1 BOTTLE
6 NDC:0234-0575-91 3790 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017768 1976-09-17


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