ESUNIX ORAL BACTERIOSTATIC GEL- cetylpyridinium chloride gel, dentifrice

Esunix Oral Bacteriostatic Gel by

Drug Labeling and Warnings

Esunix Oral Bacteriostatic Gel by is a Otc medication manufactured, distributed, or labeled by Xiling (Zhenjiang) Medical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cetylpyridinium chloride 0.06% (w/w)

PURPOSE

Oral antiseptic

DOSAGE & ADMINISTRATION

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

WARNINGS

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

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

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.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ESUNIX ORAL BACTERIOSTATIC GEL 
cetylpyridinium chloride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87118-006
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.06 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PANAX NOTOGINSENG WHOLE (UNII: E7XOU43ESD)
ECTOIN (UNII: 7GXZ3858RY)
CELLULOSE GUM (UNII: K679OBS311)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)
WATER (UNII: 059QF0KO0R)
SCUTELLARIA BAICALENSIS WHOLE (UNII: 6YF0M477I5)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
STRONTIUM CHLORIDE (UNII: EKE8PS9J6Z)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87118-006-02	10 in 1 BOX	09/21/2025
1	NDC: 87118-006-01	1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	09/21/2025

Labeler - Xiling (Zhenjiang) Medical Technology Co., Ltd. (707119039)

Registrant - Xiling (Zhenjiang) Medical Technology Co., Ltd. (707119039)

Establishment
Name	Address	ID/FEI	Business Operations
Xiling (Zhenjiang) Medical Technology Co., Ltd.		707119039	manufacture(87118-006)