CHLORAPREP by HF Acquisition Co LLC, DBA HealthFirst CHLORAPREP solution

CHLORAPREP by

Drug Labeling and Warnings

CHLORAPREP by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v

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.

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

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.

STOP USE

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

ASK DOCTOR

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

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 ºC (59-86 °F)
avoid freezing and excessive heat above 40 ºC (104 °F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHLORAPREP 
chloraprep solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1675(NDC:54365-401)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1675-1	1 in 1 POUCH	05/13/2024
1		1.75 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021555	05/13/2024

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	repack(51662-1675)