Active Ingredients
Sodium Fluoride 0.22% (0.1 w/v Fluoride ion)
Amerfresh Fluoride Gel Paste, Dentifrice
FDA Label NDC 85162-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yangzhou One & Only Personal Care Products Co., Ltd for the product Amerfresh Fluoride Gel (NDC 85162-001). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, 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
Purpose
anticavity toothpaste
Uses
Aids in the prevention of dental cavities.
Warnings
Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- do not swallow
- supervise children as necessary until capable of useing without supervision
- instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing).
- Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.
- Children under 6 years of age:do not use unless directed by a doctor or dentist.
Inactive Ingredient
Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Glycerin, anthan Gum, Sodium Benzoate, Cetylpyridinium Chloride.
Package Label.Principal Display Panel
Image Description (008)
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