Label: ANTISEPTIC SOLUTION- chlorhexidine gluconate 4% solution
- NDC Code(s): 11701-172-52
- Packager: Coloplast Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 16, 2021
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
-
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
- patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
- skin wound and general cleansing
- Warnings
- Do not use
-
When using this product
- keep out of the eyes, ears and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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
- 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 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 seperate 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
Patient preoperative skin preparation:
- apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin wound and general skin cleansing:
- 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?
- OTHER SAFETY INFORMATION
-
PRINCIPAL DISPLAY PANEL
Micro-Guard® CHG Solution
NDC 11701-172-52
Chlorhexidine Gluconate 4% Solution Antiseptic
4%
CHG Solution
Antiseptic
Non-Sterile Solution
For Single Use
Manufactured for and Distributed by:
Coloplast Corp, 1601 W River Rd N, Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.coloplast.us Product #67770
©2021-05, Coloplast Corp. Micro-Guard is a registered trademark
of Coloplast A/S. Made in the U.S.A.
4 fl. oz. (118 mL)
E21-1475
4COL04BTLLBL
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INGREDIENTS AND APPEARANCE
ANTISEPTIC SOLUTION
chlorhexidine gluconate 4% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-172 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 TRIDECYL ALCOHOL (UNII: 8I9428H868) ISOPROPYL ALCOHOL (UNII: ND2M416302) GLUCONOLACTONE (UNII: WQ29KQ9POT) COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) PEG-75 LANOLIN (UNII: 09179OX7TB) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11701-172-52 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 07/01/2021 Labeler - Coloplast Corp (110326675) Registrant - Xttrium Laboratories, Inc (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc 007470579 manufacture(11701-172)