FDA Label for Antiseptic Skin Cleanser
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- ALLERGY ALERT
- DO NOT USE
- WHEN USING THIS PRODUCT
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- SURGICAL HAND SCRUB:
- HEALTHCARE PERSONNEL HANDWASH:
- PATIENT PREOPERATIVE SKIN PREPARATION:
- SKIN WOUND AND GENERAL SKIN CLEANING:
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - MCKESSON ANTISEPTIC SKIN CLEANSER 4 FL OZ BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - MCKESSON ANTISEPTIC SKIN CLEANSER 8 FL OZ BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - MCKESSON ANTISEPTIC SKIN CLEANSER 16 FL OZ BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - MCKESSON ANTISEPTIC SKIN CLEANSER 32 FL OZ BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - MCKESSON ANTISEPTIC SKIN CLEANSER 1 GAL BOTTLE LABEL
Antiseptic Skin Cleanser Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson Medical-surgical. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Chlorhexidine gluconate 4% solution
Purpose
Antiseptic
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
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.
Do Not Use
- if you are allergic to chlorhexidine gluconate or any other ingredients in this product
- in contact with meninges
- in the genital area
- as a preoperative skin preparation of the head or face
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
Otc - Stop Use
Stop use and ask doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.
Otc - 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.
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 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
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 Cleaning:
- 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
Other Information
- store at 68-77°F (20-25°C)
- avoid excessive heat above 104°F (40°C)
Inactive Ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
Questions?
General Questions? Call 1-800-777-4908
Technical Support? Call 1-800-587-3721
Principal Display Panel - Mckesson Antiseptic Skin Cleanser 4 Fl Oz Bottle Label
NDC 68599-5401-2
4%
McKESSON
AntisepticSkin Cleanser
4% CHLORHEXIDINE GLUCONATE SOLUTION
Reduces the number of microorganisms on the skin prior to surgery or patient care.
4 fl oz
(118 mL)
DO NOT REUSE
MFR # 16-CHG4
Principal Display Panel - Mckesson Antiseptic Skin Cleanser 8 Fl Oz Bottle Label
NDC 68599-5401-3
4%
McKESSON
Antiseptic Skin Cleanser
4% CHLORHEXIDINE GLUCONATE SOLUTION
Reduces the number of microorganisms on the skin prior to surgery or patient care.
8 fl oz
(237 mL)
MFR # 16-CHG8
Principal Display Panel - Mckesson Antiseptic Skin Cleanser 16 Fl Oz Bottle Label
NDC 68599-5401-4
4%
McKESSON
Antiseptic Skin Cleanser
4% CHLORHEXIDINE GLUCONATE SOLUTION
Reduces the number of microorganisms on the skin prior to surgery or patient care.
16 fl oz
(473 mL)
MFR # 16-CHG16
Principal Display Panel - Mckesson Antiseptic Skin Cleanser 32 Fl Oz Bottle Label
NDC 68599-5401-5
4%
McKESSON
Antiseptic Skin Cleanser
4% CHLORHEXIDINE GLUCONATE SOLUTION
Reduces the number of microorganisms on the skin prior to surgery or patient care.
32 fl oz
(946 mL)
MFR # 16-CHG32
Principal Display Panel - Mckesson Antiseptic Skin Cleanser 1 Gal Bottle Label
NDC 68599-5401-6
McKESSON
Antiseptic Skin Cleanser
4% CHLORHEXIDINE GLUCONATE SOLUTION
Reduces the number of microorganisms on the skin prior to surgery or patient care.
1 gal
(3.8 L)
MFR # 16-CHGGL
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