Label: ESUNIX ORAL BACTERIOSTATIC GEL- cetylpyridinium chloride gel, dentifrice
- NDC Code(s): 87118-006-01, 87118-006-02
- Packager: Xiling (Zhenjiang) Medical Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
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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.
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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
- OTHER SAFETY INFORMATION
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ESUNIX ORAL BACTERIOSTATIC GEL
cetylpyridinium chloride gel, dentifriceProduct 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)

