FDA.reportPublic FDA data

Chlorhexidine Gluconate Applicator

Manufacturer
Miraclean Technology Co.,Ltd
Effective date
2020-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:40:58

Label at a glance#

ProductChlorhexidine Gluconate Applicator
Active ingredientISOPROPYL ALCOHOL, CHLORHEXIDINE GLUCONATE
Label structure12 sections

Dosage and administration

Peel apart the package and remove the applicator Pull and remove the ring collar lock from the handle Wet the treatment area with the fluid Press down the handle to activate and release the solution flow into the sponge pad

Storage and handling

■ Stored between 4-30℃ Avoid exclusive heat above 40℃ (104° F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate,（ 2% solution ） ，
Isopropyl alcohol,（ 70% solution ）

ask a doctor

OTC - ASK DOCTOR SECTION

If any irritation or allergic reaction occurs

Do not use

OTC - DO NOT USE SECTION

■ If any open wounds
■ If package damaged or expired
■ If the patient is allergic to chlorhexidine gluconate or any other ingredient in this product

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Purpose

OTC - PURPOSE SECTION

Antiseptic

Stop use and ask a doctor

OTC - STOP USE SECTION

If any irritation or allergic reaction occurs

Inactive ingredient

INACTIVE INGREDIENT SECTION

■ Water

Other information

STORAGE AND HANDLING SECTION

■ Stored between 4-30℃
Avoid exclusive heat above 40℃ (104° F)

Directions

DOSAGE & ADMINISTRATION SECTION

Peel apart the package and remove the applicator
Pull and remove the ring collar lock from the handle
Wet the treatment area with the fluid
Press down the handle to activate and release the solution flow into the sponge pad

Use

INDICATIONS & USAGE SECTION

For skin preparation before surgery

Warnings

WARNINGS SECTION

■ Single-use product
■ Keep away from flames or sparks
■ Keep out of the reach of children

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 10.5MLLABEL 10.5MLlabel 26mllabel 26ml

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73565-00173565-001-26, 73565-001-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9ee5676c-3662-44e1-e053-2995a90a92149ee5676c-3661-44e1-e053-2995a90a92142020-01-15WarningsExact identifier
spl id: 9ee5676c-3662-44e1-e053-2995a90a9214
spl set id: 9ee5676c-3661-44e1-e053-2995a90a9214

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.