Esunix

Manufacturer
Xiling (Zhenjiang) Medical Technology Co., Ltd.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:34:54

Label at a glance#

ProductEsunix Oral Bacteriostatic Gel
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.06% (w/w)

OTC - PURPOSE SECTION

Oral antiseptic

DOSAGE & ADMINISTRATION SECTION

Helps reduce bacteria in the mouth that may cause bad breath and oral irritation.

WARNINGS SECTION

For oral use only. Do not swallow.

Do not use in children under 6 years of age unless directed by a dentist or physician.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation, swelling, or allergic reaction occurs.

Keep out of reach of children. If more than used for application is swallowed, get medical help or contact a Poison Control Center right away.

Single-use only.

INDICATIONS & USAGE SECTION

Adults and children 6 years and older:
Apply a small amount of gel to the gums and teeth using a cotton swab or clean finger.
Allow it to remain in place for at least 30 minutes before rinsing, eating, or drinking.

Children under 6 years: Use only under the supervision of a dentist or physician.

For post-procedure care (tooth extraction, implant), follow dentist's instructions.

INACTIVE INGREDIENT SECTION

Sorbitol, Purified water, Ectoin, Cellulose gum, Glycerin, PEG-40 hydrogenated castor oil, Sodium benzoate, Strontium chloride, Panax notoginseng extract, Lonicera japonica (honeysuckle) flower extract, Portulaca oleracea (purslane) extract, Scutellaria baicalensis extract.

OTHER SAFETY INFORMATION

Store at room temperature away from light and moisture.

Do not use if seal is broken.

Expiration date: See outer package.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

002002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2723721cetylpyridinium chloride 0.06 % Oral GelPSN3
2723721cetylpyridinium chloride 0.0006 MG/MG Oral GelSCD3
2723721cetylpyridinium chloride 0.06 % Oral GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87118-006-01Esunix Oral Bacteriostatic Gel1 g in 1 TUBEGEL, DENTIFRICE13
87118-006-02Esunix Oral Bacteriostatic Gel10 in 1 BOXGEL, DENTIFRICE103

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87118-00687118-006-01, 87118-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
Esunix Oral Bacteriostatic GelCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4ee467-8142-8cb7-e063-6394a90aa7f72025-12-12WarningsExact identifier
ndc (package): 87118-006-01
ndc (package): 87118-006-02
ndc (product): 87118-006
ndc11 (package): 87118000602
ndc11 (package): 87118000601
spl id: 45bc8e85-cabf-40fc-e063-6294a90a4427
spl set id: 3f4ee467-8142-8cb7-e063-6394a90aa7f7

Reported adverse events (FAERS/openFDA)#

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