Otc - Active Ingredient
Active ingredients
Sodium Monofluorophosphate 0.76%
Atomy Anticavity Tooth Paste, Dentifrice
FDA Label NDC 52257-1470
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atomy Co., Ltd. for the product Atomy Anticavity Tooth (NDC 52257-1470). 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, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, otc - questions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anticavity
Warnings
Warnings
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
.
Dosage & Administration
Directions
Adults and children 2 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 doctor.
Children 2 to 6 years
Use only a pea-sized amount and supervise child’s brushing and rinsing (to minimize swallowing).
Children under 2 years
Ask a dentist or doctor.
Indications & Usage
Uses
Aids in the prevention of dental cavities.
Otc - Questions
Questions?
+1-253-946-2344
Inactive Ingredient
Inactive Ingredients
ARTEMISIA (WORMWOOD) LEAF EXTRACT, BUTYLENE GLYCOL, CELLULOSE GUM, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, FRAGRANCE, GLYCERIN, HYDRATED SILICA, LAURAMIDOPROPYL BETAINE, L-MENTHOL, MALTITOL, PROPOLIS EXTRACT, SILICA, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM COCOYL GLUTAMATE, SODIUM SACCHARIN, SORBITOL, STEVIA REBAUDIANA EXTRACT, TETRASODIUM PYROPHOSPHATE, WATER, XYLITOL
52257-1470-2 : Atomy Anticavity Toothpaste 50G
NDC: 52257-1470-2
ATOMY ANTICAVITY TOOTHPASTE 50g x 4 tubes
52257-1470-4 : Atomy Anticavity Toothpaste 200G
NDC: 52257-1470-4
ATOMY ANTICAVITY TOOTHPASTE 200g
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