Label: FOAMING HAND WASH- chlorhexidine gluconate liquid
- NDC Code(s): 53329-994-84
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 11, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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
When using this product
- • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
- • do not use routinely if you have wounds which involve more than the superficial layers 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.
Surgical hand scrub:
- • wet hands and forearms with water
- • scrub for 3 minutes with 5 mL of product (7 strokes) and a wet brush, paying close attention to the nails, cuticles and skin between the fingers
- • a separate nail cleaner may be used
- • rinse thoroughly
- • wash for an additional 3 minutes with 5 mL of product (7 strokes) and rinse under running water and dry thoroughly
Healthcare personnel handwash:
- • wet hands with water
- • dispense 5 mL of product (7 strokes) into cupped hands and wash in a vigorous manner for 15 seconds
- • rinse and dry thoroughly
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
FOAMING HAND WASH
chlorhexidine gluconate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-994 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) ISOPROPYL ALCOHOL (UNII: ND2M416302) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-994-84 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 01/01/2020 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
