Drugplain

Antiseptic Solution 4 g/100mL

Chlorhexidine Gluconate 4% · SOLUTION · Coloplast Corp

2 Recalls on Record
Plain English

Antiseptic Solution is a solution containing chlorhexidine gluconate 4% at 4 g/100mL, taken topical. Manufactured by Coloplast Corp.

Key Facts

Brand Name
Antiseptic Solution
Generic Name
Chlorhexidine Gluconate 4%
NDC Code (Product)
11701-172
Manufacturer
Coloplast Corp
Strength
4 g/100mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
NDA019125
Marketing Start
07/01/2021

Recall History

2 Recalls on Record
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

alopecia2 reports
burkholderia infection2 reports
complication of device insertion2 reports
eye irritation2 reports
hypersensitivity2 reports
pain2 reports
procedural pain2 reports
rash2 reports
sepsis2 reports
sputum culture positive2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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.

Frequently Asked Questions

What is Antiseptic Solution used for?

Antiseptic Solution contains Chlorhexidine Gluconate 4%. It is a solution taken topical. Consult your doctor for specific uses.

Is Antiseptic Solution a controlled substance?

Antiseptic Solution is not classified as a controlled substance by the DEA.

What is the generic name for Antiseptic Solution?

The generic name for Antiseptic Solution is Chlorhexidine Gluconate 4%. There are 11 other brand versions of Chlorhexidine Gluconate 4%.

What is the NDC code for Antiseptic Solution 4 g/100mL?

The NDC (National Drug Code) for Antiseptic Solution 4 g/100mL is 11701-172, listed by Coloplast Corp.