Otc - Active Ingredient
Cetylpyridinium chloride 0.06% (w/w)
Esunix Oral Bacteriostatic Gel Gel, Dentifrice
FDA Label NDC 87118-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xiling (zhenjiang) Medical Technology Co., Ltd. for the product Esunix Oral Bacteriostatic Gel (NDC 87118-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, indications & usage, inactive ingredient, other safety information, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Keep Out Of Reach Of Children
keep out of reach of children
Package Label.Principal Display Panel
002 (002)
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