NDC | 21749-225-56, 21749-225-57, 21749-225-58 |
Set ID | 6c7e63c2-428b-2be2-e053-2a91aa0a6af3 |
Category | HUMAN OTC DRUG LABEL |
Packager | GOJO Industries, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA019422 |
- 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 permenant 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
- Stop use and ask a doctor if
- Keep out of reach of children
-
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 5mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
rinse and dry throughly
Surgical hand scrub:
wet hands and forearms with water
scrub for 3 minutes with 5mL 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 5mL of product (6 full strokes) and rinse under running water and dry throughly
- Other information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL
Purell
Healthcare
FOAM HANDWASH
2% CHG
Antimicrobial Foam
GOJOCSFLBLA
7887-641-F
NDC 21749-225-58
Purell
Healthcare FOAM HANDWASH 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.
GOJOCS4BLBLA
5181-642-ES-B
42 fl oz (1250 mL)
NDC 21749-225-57
Purell
Healthcare FOAM HANDWASH 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.
GOJOCS6BLBLA
6581-642-ES-B
40.5 FL OZ (1200 mL)
NDC 21749-225-56
Purell
Healthcare FOAM HANDWASH 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 the USA with U.S. and foreign components
GOJOCS8BLBLA
7881-641-ES-B
40.5 FL OZ (1200 mL)
-
PRINCIPAL DISPLAY PANEL
HEALTHCARE
PURELL
FOAM
HANDWASH
CHLORHEXIDINE GLUCONATE
2% SOLUTION - ANTISEPTIC
40.5 fl oz (1200 mL)
GOJOESFLBL
7781-640-F
NDC 21749-225-64
Purell
Healthcare
FOAM HANDWASH
2% CHG Antimicrobial Foam
40.5 fl oz (1200 mL)
GOJOES4BLBL
5081-640-B
NDC 21749-225-68
Purell
Healthcare
FOAM HANDWASH
2% CHG Antimicrobial Foam
40.5 fl oz (1200 mL)
GOJOES8BLBL
7781-640-B
-
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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) COCO DIETHANOLAMIDE (UNII: 92005F972D) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21749-225-58 1250 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 2 NDC:21749-225-57 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 3 NDC:21749-225-56 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018 4 NDC:21749-225-64 1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2019 5 NDC:21749-225-68 1200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 09/01/2019 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)