FDA.reportPublic FDA data

Chlorhexidine Gluconate - Xinxiang Xinda Technology Co.,Ltd

Manufacturer
Xinxiang Xinda Technology Co.,Ltd
Effective date
2026-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-13 05:10:12

Label at a glance#

ProductSponge with 4% w/w chlorhexidine gluconate (CHG)
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure8 sections

Dosage and administration

• Wet the health skin with water. Rinse for 2 to 3 minutes and rub skin to produce foam. • Clarify with water and dry with a sterile towel.

Storage and handling

● Store at 20-25° (68-77°F). ● Avoid overheating 40°C (104 F) ● Discard after single use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine Gluconate Solution,4%, 20ml

Purpose

OTC - PURPOSE SECTION

Surgical Healthy Skin Scrub

Use

INDICATIONS & USAGE SECTION

Preoperative cleaning of healthy skin,disinfectant for human hygiene.Significantly reduces the number of micro-organisms and clean on the health skin prior to surgery.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

it for a long time .

if redness or irritation occurs.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

severe adverse reactions occur.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed or gets in eyes,get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet the health skin with water. Rinse for 2 to 3 minutes and rub skin to produce foam.

• Clarify with water and dry with a sterile towel.

Other information

STORAGE AND HANDLING SECTION

● Store at 20-25° (68-77°F).
● Avoid overheating 40°C (104 F)
● Discard after single use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cocamide DEA, Fragrance POFL147, Glucono-deltalactone, Hydroxyethylcellulose, Iso-Propyl alcohol, Lauramine oxide, Glycerol, Alkyl Polyglycoside, Purified Water

84128-013-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2020

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136977191590105GTIN-13: 6977191590105
EAN-13: 6977191590105
GTIN storage (14 digits): 06977191590105		84128-013-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84128-01384128-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB

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
Sponge with 4% w/w chlorhexidine gluconate (CHG)CHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd53f4dd22-e4ab-5d8a-e063-6294a90a8c392026-06-11WarningsExact identifier
ndc (package): 84128-013-01
ndc (product): 84128-013
ndc11 (package): 84128001301
spl id: 53f4c42d-9a3c-2f33-e063-6294a90a98d4
spl set id: 53f4dd22-e4ab-5d8a-e063-6294a90a8c39

Reported adverse events (FAERS/openFDA)#

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