Active ingredientCHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL
Label structure10 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 13.2 in. x 13.2 in. (1126 cm 2 ). Do not use 26-ml applicator for area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead, do not use 26-ml applicator for head and neck surgery remove applica...
Storage and handling
store between 15-30 °C (59-86 °F) avoid freezing and excessive heat above 40 °C (104 °F)
do not use 26-ml applicator for head and neck surgery or on an area smaller than 8.4 in. × 8.4 in. Use a smaller applicator instead.
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 the risk of fire; PREP CAREFULLY:
do not use 26-mL applicator for head and neck surgery
do not use on an area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
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:
wheezing/difficulty breathing
shock
facial swelling
hives
rash
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 meningea
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 - ASK DOCTOR 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
13.2 in. x 13.2 in. (1126 cm
2). Do not use 26-ml applicator
for area smaller than 8.4 in. x 8.4 in. Use a smaller
applicator instead,
do not use 26-ml applicator for head and neck surgery
remove applicator from package; do not touch sponge
hold applicator with the sponge down. Pinch wing
only once to activate the ampules 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 for 30 seconds
moist surgical sites (e.g., inguinal fold): use gentle
repeated back-and-forth strokes for 2 minutes
do not allow solution to pool; tuck prep towels to absorb
solution, and then remove
allow 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
STORAGE AND HANDLING SECTION
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.
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