Dawnmist Fluoride Paste
FDA Label NDC 65517-2017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dukal Llc for the product Dawnmist Fluoride (NDC 65517-2017). 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 dawnmist gel fluoride toothpaste, active ingredient, purpose, use, keep out of reach of children under 6 years of age, directions, inactive ingredient, label image, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.22%
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Keep Out Of Reach Of Children Under 6 Years Of Age
If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control immediately
Directions
Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
Children under 6 years: To minimize swallowing, use a peas sized amount and supervisor brushing until good habits are established.
Children under 2 years: Ask a dentist or physician
Inactive Ingredient
Sorbitol, Water, Silica, Sodium Lauryl Sulphate, PEG1500, Flavor, Carboxymethyl Cellulose, Sodium Benzoate, Sodium Saccharin
Label Image
DawnMist Gel Fluoride Toothpaste 78g (65517-2017-0)
DawnMist Gel Fluoride Toothpaste 17g (65517-2017-1)
DawnMist Gel Fluoride Toothpaste 24g (65517-2017-2)
DawnMist Gel Fluoride Toothpaste 43g (65517-2017-3)
Manufactured for:
DUKAL CORPORATION
Ronkonkoma, NY 11779
(631) 656-3800
Made in India
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