SPL v1
SPL
SPL Set ID 44fe08e0-4e9c-8bd6-e063-6394a90a0e2b
Route
TOPICAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.7 mL) Chlorhexidine (20 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2024-05-13

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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Raw Label Data

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