Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution
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NDC Code(s):
0116-1061-01,
0116-1061-08,
0116-1061-16,
0116-1061-18, view more0116-1061-32, 0116-1061-40
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Drug Facts
- 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.
Do not use
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if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
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in contact with meninges
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in the genital area
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as a preoperative skin preparation of the head or face (only in 4-oz)
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 which 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
- Do not use
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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 which involve more than the superficial layers of the skin should not be routinely treated
- repeated general skin cleansing of large body areas shold not be done except when advised by a health care provider
- Stop use and ask doctor if
- Keep out of reach of children
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Direction
- use with care in premature infants and 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 about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces
- a separate nail cleaner may be used
- rinse thoroughly
- wash for an additional 3 minutes with 5 ml of product and rinse under running water
- 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
- Inactive ingredients
- Questions or comments?
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Package label and principal display panel
NDC 0116-1061-08
DYNA-HEX 4 ®
(Chlorhexidine Gluconate 4% Solution)
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 8 fl oz (237 mL)
4DY08BTLLBLF
NDC 0116-1061-16
DYNA-HEX 4 ®
(Chlorhexidine Gluconate 4% Solution)
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 16 fl oz (473 mL)
4DY16BTLLBLF
NDC 0116-1061-32
DYNA-HEX 4 ®
(Chlorhexidine Gluconate 4% Solution)
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 32 fl oz (946 mL)
4DY32BTLLBLB
NDC 0116-1061-01
DYNA-HEX 4 ®
(Chlorhexidine Gluconate 4% Solution)
Antiseptic
Contains: 4% Chlorhexidine Gluconate
Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 128 fl oz (1 gal)
4DYN1GBTLLBLC
NDC 0116-1061-40
DYNA-HEX 4®
Chlorhexidine Gluconate 4% Solution
Antiseptic
Contains:
4% Chlorhexidine Gluconate With foam pump
Distributed By:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 4 fl oz (118mL)
4DY04FM1061LBLB
NDC 0116-1061-18
DYNA-HEX 4®
Chlorhexidine Gluconate 4% Solution
Antiseptic
Contains:
4% Chlorhexidine Gluconate
Distributed By:
Xttrium Laboratories, Inc.
Mount Prospect, IL 60056
FOR EXTERNAL USE ONLY
Net Contents: 18 fl oz (532mL)
4DY18FM1061LBLB
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INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-1061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) GLUCONOLACTONE (UNII: WQ29KQ9POT) PEG-75 LANOLIN (UNII: 09179OX7TB) COCO DIETHANOLAMIDE (UNII: 92005F972D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-1061-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2011 2 NDC:0116-1061-16 437 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2011 3 NDC:0116-1061-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/31/2011 4 NDC:0116-1061-01 15142 mL in 1 JUG; Type 0: Not a Combination Product 08/31/2011 5 NDC:0116-1061-40 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 6 NDC:0116-1061-18 532 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 08/31/2011 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-1061)