Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL
Label structure16 sections
Dosage and administration
• use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. • use in a well ventilated area • maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm 2 ) • remove applicator from package; do not touch sponge • hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. •...
solution contains alcohol and gives off
flammable vapors
avoid getting solution into hairy areas. Hair may take up to 1 hour to dry.
Wet hair is flammable.
do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry
(minimum of 3 minutes on hairless skin; up to 1 hour in hair)
do not allow solution to pool
remove wet materials from prep area
Active ingredients
OTC - ACTIVE INGREDIENT SECTION
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
Purposes
OTC - PURPOSE SECTION
Antiseptic
Antiseptic
Use
INDICATIONS & USAGE SECTION
for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Warnings
WARNINGS SECTION
For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY:
solution contains alcohol and gives off
flammable vapors
avoid getting solution into hairy areas. Hair may take up to 1 hour to dry.
Wet hair is flammable.
do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry
(minimum of 3 minutes on hairless skin; up to 1 hour in hair)
do not allow solution to pool
remove wet materials from prep area
Allergy alert:
WARNINGS SECTION
This product may cause a severe allergic reaction. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
OTC - DO NOT USE SECTION
• 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
When using this product
OTC - WHEN USING SECTION
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.
Stop use and ask a doctor if
OTC - STOP USE SECTION
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
DOSAGE & ADMINISTRATION SECTION
• use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
• use in a well ventilated area
• maximal treatment area for one applicator is approximately
4 in. x 5 in. (130 cm
2)
• remove applicator from package; do not touch sponge
• hold the applicator with the sponge down. Pinch wings
only once to activate the ampule and release the antiseptic.
• wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
• completely wet the treatment area with antiseptic
•
dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes of the sponge for approximately 30 seconds. Allow solution to air dry for approximately 30 seconds. Do not blot or wipe away.
•
moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes of the sponge for approximately 2 minutes. Allow solution to air dry for approximately 1 minute. Do not blot or wipe away.
•
if using an ignition source, allow the solution to completely dry(minimum of 3 minutes on hairless skin; up to 1 hour in hair). 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.
Other Information
OTHER SAFETY INFORMATION
• store between 15-30 °C (59-86 °F)
• avoid freezing and excessive heat above 40 °C (104 °F)
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 129 observed states.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.