Antiseptic Skin Cleanser

Antiseptic Skin Cleanser
SPL v1
SPL
SPL Set ID 76cfedb3-25ed-4c12-8ebc-b57f029fedaa
Route
TOPICAL
Published
Effective Date 2012-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Gluconolactone Hydroxyethyl Cellulose (1500 Mpa.s At 1%) Isopropyl Alcohol Lauramine Oxide Peg-75 Lanolin Water Tridecyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
EXPORT ONLY Active Since 2012-12-06

Description

Drug Facts

Purpose

surgical hand scrub healthcare personnel handwash patient preoperative skin preparation skin wound and general skin cleansing


Medication Information

Purpose

surgical hand scrub healthcare personnel handwash patient preoperative skin preparation skin wound and general skin cleansing

Description

Drug Facts

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
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing
Section 42229-5

Drug Facts

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.

Purposes

surgical hand scrub

healthcare personnel handwash

patient preoperative skin preparation

skin wound and general skin cleansing

Warnings

For external use only

Do Not Use
  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face
Active Ingredient

Chlorhexidine gluconate 4% solution

Other Information
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Surgical Hand Scrub
  • wet hands and forearms under running water
  • scrub for 3 minutes with about 5 ml of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of product and rinse under running water
  • dry thoroughly
Inactive Ingredients

fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions Or Comments?

Call 1-855-552-8274

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 solution should contact these areas, rinse out promptly and thoroughly with water
  • 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 the underlying condition makes it necessary to reduce the bacterial population of the skin
Healthcare Personnel Handwash
  • wet hands with water
  • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly
Patient Preoperative Skin Preparation
  • apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin Wound and General Skin Cleansing
  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly
Principal Display Panel 947 Ml Bottle Label

NDC 42939-102-04

ANTISEPTIC SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

32 fl.oz. (974 mL)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

AVA Incorporated

Lot:

Exp:


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
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing
Section 42229-5 (42229-5)

Drug Facts

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.

Purposes

surgical hand scrub

healthcare personnel handwash

patient preoperative skin preparation

skin wound and general skin cleansing

Warnings

For external use only

Do Not Use (Do not use)
  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face
Active Ingredient (Active ingredient)

Chlorhexidine gluconate 4% solution

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Surgical Hand Scrub (Surgical hand scrub)
  • wet hands and forearms under running water
  • scrub for 3 minutes with about 5 ml of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 ml of product and rinse under running water
  • dry thoroughly
Inactive Ingredients (Inactive ingredients)

fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions Or Comments? (Questions or comments?)

Call 1-855-552-8274

When Using This Product (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 solution should contact these areas, rinse out promptly and thoroughly with water
  • 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 the underlying condition makes it necessary to reduce the bacterial population of the skin
Healthcare Personnel Handwash (Healthcare personnel handwash)
  • wet hands with water
  • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly
Patient Preoperative Skin Preparation (Patient preoperative skin preparation)
  • apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin Wound and General Skin Cleansing (Skin wound and general skin cleansing)
  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly
Principal Display Panel 947 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 947 mL Bottle Label)

NDC 42939-102-04

ANTISEPTIC SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

32 fl.oz. (974 mL)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

AVA Incorporated

Lot:

Exp:


Advanced Ingredient Data


Raw Label Data

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