Otc - Active Ingredient
Cetylpyridinium chloride 0.05% (w/w)
Esunix Oral Bacteriostatic Liquid
FDA Label NDC 87118-005
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 Liquid (NDC 87118-005). 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, otc - keep out of reach of children, package label.principal display panel, 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
Adults and children 6 years and older:
Use after brushing. Tear open one pouch and pour into mouth. Gargle for 20 seconds, then spit out. Do not rinse with water.
Children under 6 years:
Use only under the supervision of a dentist or physician.
Warnings
For oral use only. Do not swallow.
Accidental ingestion of small amounts is not expected to cause harm.
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if irritation or allergic reaction occurs.
Keep out of reach of children. If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Helps reduce bacteria in the mouth that may cause bad breath and oral discomfort.
Inactive Ingredient
Purified water, Sorbitol, PEG-40 hydrogenated castor oil, Glycerin, Propylparaben, Fragrance, Sodium benzoate, Lonicera japonica flower extract, Prunus speciosa flower extract, Glycyrrhiza uralensis extract, Camellia sinensis polyphenols, Sodium citrate, Menthol, Sucralose.
Otc - Keep Out Of Reach Of Children
keep out of reach of children section
Package Label.Principal Display Panel
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