Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution
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NDC Code(s):
68599-5401-0,
68599-5401-1,
68599-5401-2,
68599-5401-3, view more68599-5401-4, 68599-5401-5, 68599-5401-6, 68599-5401-7, 68599-5401-8, 68599-5401-9
- Packager: McKesson Medical-Surgical
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 13, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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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
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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
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Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
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
- 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
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INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-5401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) GLUCONOLACTONE (UNII: WQ29KQ9POT) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) PEG-75 LANOLIN (UNII: 09179OX7TB) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-5401-1 48 in 1 CASE 06/01/2017 1 NDC:68599-5401-2 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68599-5401-7 24 in 1 CASE 06/01/2017 2 NDC:68599-5401-3 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:68599-5401-8 12 in 1 CASE 06/01/2017 3 NDC:68599-5401-4 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:68599-5401-9 12 in 1 CASE 06/01/2017 4 NDC:68599-5401-5 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:68599-5401-0 4 in 1 CASE 06/01/2017 5 NDC:68599-5401-6 3800 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 06/01/2017 Labeler - McKesson Medical-Surgical (023904428) Establishment Name Address ID/FEI Business Operations XTTRIUM LABORATORIES, INC. 007470579 manufacture(68599-5401)