SPL v1
SPL
SPL Set ID f5cf0e60-9e0a-75b0-e053-2a95a90aeba3
Route
TOPICAL
Published
Effective Date 2023-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (40 mg)
Inactive Ingredients
Cocamine Oxide Hydroxyethyl Cellulose (3000 Cps At 1%) Peg-150 Distearate Gluconolactone Peg-75 Lanolin Coco Diethanolamide Propylene Glycol Quaternium-33 Water Isopropyl Alcohol Gluconic Acid

Identifiers & Packaging

Marketing Status
NDA Active Since 2021-11-17

Description

Active ingredient Chlorhexidine gluconate solution, 4%


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease
  • skin wound and general skin cleanser: helps reduce bacteria on the skin
Dosage and Administration

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • use full strength
  • do not dilute

Surgical hand scrub:

  • remove jewelry
  • wet hands and forearms with water and apply 5 mL of the product
  • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • rinse thoroughly with water
  • wash for an additional 3 minutes with 5 mL of the product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleanser:

  • thoroughly rinse the area to be cleansed with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
  • rinse again thoroughly
Description

Active ingredient Chlorhexidine gluconate solution, 4%

Section 44425-7

Other information

  • store between 20-25°C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
  • for additional information, see Safety Data Sheet (SDS)
  • if swallowed get medical help or contact a Poison Control Center immediately
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 and lasts for 72 hours. These may be signs of a serious condition.

Section 50567-7

When using this product

  • 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, rinse with cold water right away
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when an underlying condition makes it necessary to reduce the bacterial population of the skin
Section 50570-1

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredient in this preparation
  • as a patient preoperative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
Section 51727-6

Inactive ingredients

cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

*contains one or more of these ingredients

Section 51945-4

NDC 0404-0175-02

Maxiclens TM

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4%)

FOR EXTERNAL USE ONLY

Distributed By

HENRY SCHEIN INC.

135 Duryea Road

Melville, NY 11747 USA

Net Contents

32 fl oz (1 qt)(946-mL)

Made in U.S.A.

Product Made in U.S.A.

Keep from freezing.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers

will cause stains if used with chlorine releasing products, such as chlorine

bleach. Rinse completely and use only non-chlorine detergents.

WARNING: This product can expose you to coconut oil diethanolamine condensate

(cocamide diethanolamine), which is known to the State of California to cause

cancer. For more information go to www.P65Warnings.ca.gov

Section 53413-1

Questions or comments?

Call 1-800-581-2528 Monday through Friday 8:00 AM to 5:00 PM EST

Section 55105-1

Purposes

Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser

Section 55106-9

Active ingredient

Chlorhexidine gluconate solution, 4%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease
  • skin wound and general skin cleanser: helps reduce bacteria on the skin
Dosage and Administration (34068-7)

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • use full strength
  • do not dilute

Surgical hand scrub:

  • remove jewelry
  • wet hands and forearms with water and apply 5 mL of the product
  • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
  • rinse thoroughly with water
  • wash for an additional 3 minutes with 5 mL of the product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 30 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleanser:

  • thoroughly rinse the area to be cleansed with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
  • rinse again thoroughly
Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

Other information

  • store between 20-25°C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
  • for additional information, see Safety Data Sheet (SDS)
  • if swallowed get medical help or contact a Poison Control Center immediately
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 and lasts for 72 hours. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

  • 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, rinse with cold water right away
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when an underlying condition makes it necessary to reduce the bacterial population of the skin
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredient in this preparation
  • as a patient preoperative skin preparation (especially on the head or face)
  • in contact with meninges
  • in the genital area
Section 51727-6 (51727-6)

Inactive ingredients

cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyethyl cellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

*contains one or more of these ingredients

Section 51945-4 (51945-4)

NDC 0404-0175-02

Maxiclens TM

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4%)

FOR EXTERNAL USE ONLY

Distributed By

HENRY SCHEIN INC.

135 Duryea Road

Melville, NY 11747 USA

Net Contents

32 fl oz (1 qt)(946-mL)

Made in U.S.A.

Product Made in U.S.A.

Keep from freezing.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers

will cause stains if used with chlorine releasing products, such as chlorine

bleach. Rinse completely and use only non-chlorine detergents.

WARNING: This product can expose you to coconut oil diethanolamine condensate

(cocamide diethanolamine), which is known to the State of California to cause

cancer. For more information go to www.P65Warnings.ca.gov

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-581-2528 Monday through Friday 8:00 AM to 5:00 PM EST

Section 55105-1 (55105-1)

Purposes

Surgical hand scrub Healthcare personnel handwash Skin wound and general skin cleanser

Section 55106-9 (55106-9)

Active ingredient

Chlorhexidine gluconate solution, 4%


Advanced Ingredient Data


Raw Label Data

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