Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Cetylpyridinium chloride 0.06% (w/w)
OTC - PURPOSE SECTION
Oral antiseptic
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
Key Label Information#
Uses
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.
Warnings
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.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Helps reduce bacteria in the mouth that may cause bad breath and oral irritation.
Other Label Information
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.
Label Images#
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87118-006-01 | Esunix Oral Bacteriostatic Gel | 1 g in 1 TUBE | GEL, DENTIFRICE | 1 | 3 | |
| 87118-006-02 | Esunix Oral Bacteriostatic Gel | 10 in 1 BOX | GEL, DENTIFRICE | 10 | 3 |
Products#
- Esunix Oral Bacteriostatic Gel
- CETYLPYRIDINIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87118-006 | 87118-006-01, 87118-006-02 |
Ingredients#
Complete SPL Sections#
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