Label: PURELL ANTIMICROBIAL FOAM- chlorhexidine gluconate 2% solution liquid
- NDC Code(s): 21749-225-53
- Packager: GOJO Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 18, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
-
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 invlove more than the superficial layers of the skin
- Stop use and ask doctor if
- Keep out of reach of children.
-
Directions
use with care in premature infants or infants under two months of age. These products may cuase irritation or chemical burns
Healthcare personnel handwash:
wet hands with water
dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
rinse and dry thoroughly
Surgical hand scrub
wet hands and forearms with water
scrub for 3 minutes with 5 mL of product (6 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
a seperate nail cleaner may be used
rinse thoroughly
wash for an additional 3 minutes with 5 mL of product (6 full strokes) and rinse under running water and dry thoroughly
- Other information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL
NDC 21749-225-53
Purell
FOAM HANDWASH
Chlorhexidine Gluconate 2% Solution - Antiseptic
Broad spectrum kill
Gentle on hands
2% CHG ANTIMICROBIAL FOAM
Distributed by:
GOJO Industries, Inc.
Akron, OH 44309
800-321-9647 • 330-255-6000
www.GOJO.com
©2019. GOJO Industries, Inc.
All rights reserved., Made in U.S.A.
Reorder 5742-06
GOJOBLUE18LBLB
5742-643
-
INGREDIENTS AND APPEARANCE
PURELL ANTIMICROBIAL FOAM
chlorhexidine gluconate 2% solution liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-225 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 HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21749-225-53 535 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 02/01/2018 Labeler - GOJO Industries, Inc. (004162038) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(21749-225)