DYNA-HEX 2- chlorhexidine gluconate liquid

DYNA-HEX by

Drug Labeling and Warnings

DYNA-HEX by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

chlorhexidine gluconate 2% solution

Purpose

Antiseptic

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
• skin wound and general skin cleansing

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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
• in contact with meninges
• in the genital area

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 irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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 seconds

rinse 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

• store at 20-25° C (68-77° F)
• avoid excessive heat above 40° C (104° F)

Inactive ingredients

citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

call 1-800-587-3721
Monday through Friday 8:00 AM to 4:30 PM CST

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: 0116-1021-16

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 liquid

Product 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

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)