Active Ingredient
SODIUM FLUORIDE 0.05%
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash Liquid
FDA Label NDC 73928-051
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kingkey Mbc Life Technology Group Co., Ltd. for the product Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash (NDC 73928-051). 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 active ingredient, purpose, warnings, uses, directions, inactive ingredients, 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
Purpose
（0.02% w/v fluoride ion)----Anticavity
Warnings
Keep out of reach of children under 6 years of age.lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.
Keep out of reach of children under 6 years of age, lf youaccidentally swallow more than used for rinsing, seek professionahelp or contact a Poison Control Center immediately.
Uses
helps protect teeth against cavities.
Directions
Adults and children 6 years and older:
- Use daily after you brush your teeth with toothpaste
- Rinse toothpaste from mouth prior to use.
- Shake well before each use.
- Twist and remove cap.
- Rinse or gargle for 30 seconds with 15 ml and spit out
- Do Not swallow the rinse.
- Do Not eat or drink for 30 minutes after rinsing Supervise children as necessary.
- Children under 6 years of age, consult with a dentist or doctor.
Inactive Ingredients
Water
SORBITOL
GLYCERIN
XYLITOL
SODIUM BENZOATE
POTASSIUM SORBATE
PEG-40 HYDROGENATED CASTOR OIL
MENTHA HAPLOCALYX OIL
SODIUM SACCHARIN
CETYLPYRIDINIUM CHLORIDE
METHYL DIISOPROPYL PROPIONAMIDE
SUCRALOSE
CITRIC ACID
Package Label.Principal Display Panel
Label (Mouthwash Compressed)
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