44fe08e0-4e9c-8bd6-e063-6394a90a0e2b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v
Medication Information
Warnings and Precautions
For external use only. Flammable, keep away from fire or flame.
do not use with electrocautery procedures
Indications and Usage
for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Dosage and 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.
Description
Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v
Section 50565-1
If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Section 50567-7
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.
Section 50569-3
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Section 50570-1
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
Section 51727-6
USP purified water
Section 51945-4
Section 55105-1
Antiseptic
Section 55106-9
Chlorhexidine gluconate (CHG), 2% w/v
and Isopropyl alcohol (IPA), 70% v/v
Section 60561-8
store between 15-30 ºC (59-86 °F)
avoid freezing and excessive heat above 40 ºC (104 °F)
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.
Structured Label Content
Indications and Usage (34067-9)
for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Dosage and Administration (34068-7)
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.
Warnings and Precautions (34071-1)
For external use only. Flammable, keep away from fire or flame.
do not use with electrocautery procedures
Section 50565-1 (50565-1)
If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Section 50567-7 (50567-7)
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.
Section 50569-3 (50569-3)
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
USP purified water
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Antiseptic
Section 55106-9 (55106-9)
Chlorhexidine gluconate (CHG), 2% w/v
and Isopropyl alcohol (IPA), 70% v/v
Section 60561-8 (60561-8)
store between 15-30 ºC (59-86 °F)
avoid freezing and excessive heat above 40 ºC (104 °F)
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.
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Source: dailymed · Ingested: 2026-02-15T12:07:25.902328 · Updated: 2026-03-14T23:10:51.714911