Otc - Active Ingredient
SODIUM FLUORIDE 0.05%
Wpgcng Antiacvity Fluoride Mouthwash Liquid
FDA Label NDC 73928-544
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 Wpgcng Antiacvity Fluoride Mouthwash (NDC 73928-544). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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
Anticavity
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age
Indications & Usage
Adults and children 6 years of age and older:
Use once a day after brushing your teeth with a toothpaste.
- Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then split out.
- Do Not swallow the rinse.
- Do Not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in good rinsing habits(to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Consult a dentist or doctor.
Warnings
Keep out of reach of children under 6 years of age, lf you accidentally swallow more than used for rinsing, seek professionalhelp or contact a Poison Control Center immediately. Call professional help at 1-800-222-1222 or go to PoisionHelp.org.
Dosage & Administration
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 Ingredient
Water, Sorbitol, Glycerin, Xylitol, Potassium Sorbate,Sodium Benzoate, PEG-40 Hydrogenated Castor Oil,Flavor, Sodium Saccharin,Cetylpyridinium Chloride,Sucralose, Citric Acid, Methyl DiisopropylPropionamide,FD&C Yellow No.5 (CI 19140), FD&CBlue No.1 (CI42090)
Package Label.Principal Display Panel
Label (Mouthwash Compressed)
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