NDC | 0116-1021-01, 0116-1021-08, 0116-1021-16, 0116-1021-17, 0116-1021-32 |
Set ID | 6cc89ac1-baef-40bb-85a3-d9ae9e3e7a63 |
Category | HUMAN OTC DRUG LABEL |
Packager | Xttrium Laboratories, 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 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
- wounds that 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 advised by a health care provider
- 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.
Surgical hand scrub:
wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
rinse thoroughly under running water for 30 seconds
wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
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 secondsrinse and dry thoroughly
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
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
NDC 0116-1021-08
Chlorhexidine Gluconate 2% Solution
Antiseptic Foam Handwash
Distributed by:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2BLDY08BTLLBLB
Dyna-Hex ®
Net Wt 8 fl oz (237 mL)
NDC 0116-1021-85
DYNA-HEX 2®
ANTIMICROBIAL HAND SOAP
Chlorhexidine Gluconate 2% Solution
Antiseptic
Contains: 2% Chlorhxidine Gluconate
FOR EXTERNAL USE ONLY
FDA approved formula
Helps Reduce Bacteria
Fragrance-Free
Used by Healthcare personnel in hospitals
Net Contents: 8.5 fl oz (251 mL)
2DYN85FLBL
NDC 0116-1021-16
Chlorhexidine Gluconate 2% Solution
Antiseptic Foam Handwash
Distributed by:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2DYN16BTLLBLC
Dyna-Hex ®
Net Wt 16 fl oz (473 mL)
NDC 0116-1021-17
Chlorhexidine Gluconate 2% Solution
Antiseptic Foam Handwash
Distributed by:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2BLDYNATLBLD
Dyna-Hex ®
Net Wt 16 fl oz (473 mL)
NDC 0116-1021-32
Chlorhexidine Gluconate 2% Solution
Antiseptic Foam Handwash
Distributed by:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2DYN32BTLLBLA
Dyna-Hex ®
Net Wt 32 fl oz (946 mL)
NDC 0116-1021-01
Chlorhexidine Gluconate 2% Solution
Antiseptic Foam Handwash
Distributed by:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
2DYN1GBTLLBLA
Dyna-Hex ®
Net Wt 128 fl oz (1 gal)
-
INGREDIENTS AND APPEARANCE
DYNA-HEX 2
chlorhexidine gluconate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-1021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-1021-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2014 2 NDC:0116-1021-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2014 3 NDC:0116-1021-17 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2014 4 NDC:0116-1021-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2014 5 NDC:0116-1021-01 15142 mL in 1 JUG; Type 0: Not a Combination Product 01/01/2014 6 NDC:0116-1021-85 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 01/01/2014 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-1021)