Otc - Active Ingredient
Chlorhexidine gluconate (CHG), 2% w/v
and Isopropyl alcohol (IPA), 70% v/v
Chloraprep Solution
FDA Label NDC 51662-1675
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hf Acquisition Co Llc, Dba Healthfirst for the product Chloraprep (NDC 51662-1675). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, allegery alert, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Warnings
For external use only. Flammable, keep away from fire or flame.
do not use with electrocautery procedures
Allegery 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.
Otc - Do Not Use
on patients allergic to chlorhexidine gluconate or any other ingredient in this product
for lumbar puncture or in contact with the meninges
on open skin wounds or as a general skin cleanser
Otc - When Using
keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
Otc - Stop Use
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Otc - Ask Doctor
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
maximal treatment area for one applicator
one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
completely wet the treatment area with antiseptic
dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 2 minutes). Allow the area to air dry for approximately 1 minute. Do not blot or wipe away.
discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.
Inactive Ingredient
USP purified water
Other Safety Information
store between 15-30 °C (59-86 °F)
avoid freezing and excessive heat above 40 °C (104 °F)
* Please review the disclaimer below.
