Otc - Active Ingredient
sodium fluroide 0.22 % anticavity
Dawnmist
FDA Label NDC 55504-4341
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Donavan for the product Dawnmist (NDC 55504-4341). 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, inactive ingredient, dosage & administration, indications & usage, otc - purpose, otc - keep out of reach of children, warnings, user safety warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
calcium carbonate, water, sorbitol, silica, sodium lauryl sulphate, flavor, carboxyl methyl cellulose, sodium benzoate, sodium saccharin, potassium nitrate, menthol
Dosage & Administration
adults and children 2 yrs. 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 yrs.: to minimize swallowing use a pea sized amount and supervise brushing until good habits are established.
children under 2 years: ask a dentist or physician.
Indications & Usage
aids in the prevention of dental cavities.
Otc - Purpose
Aids in the prevention of dental cavities.
Otc - Keep Out Of Reach Of Children
keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing seek professional assistance or contact a poison control center immediately.
Warnings
Keep out of reach of children under 6 years of age. if you accidentally
swallow more than used for brushing seek professional assistance or
contact a poison control center immediately.
User Safety Warnings
expiration date: expiration date and batch no. on crimp of tube.
Package Label.Principal Display Panel
dawnmist anticavity fluoride toothpaste.
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