Otc - Purpose
helps protect against cavities
3ecare Dual Formulawhiteningtoothpaste Paste, Dentifrice
FDA Label NDC 87514-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hangzhou Namei Zhikang Technology Co., Ltd. for the product 3ecare Dual Formulawhiteningtoothpaste (NDC 87514-003). 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 - purpose, warnings, otc - keep out of reach of children, instructions for use, dosage & administration, inactive ingredient, indications & usage, recent major changes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
It shall be used with electric dual toothpaste dispenser.
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
Keep out of reach of children. If more than used for brushing is
accidentally swallowed, get medical help or contact a Poison
Control Center right away.
Instructions For Use
①Please use it with electric dual toothpaste dispenser;
②Mount dual-formula toothpaste on the electric dispenser according to the instructions for use;
③For the first use, unscrew the cap and remove the sealing sticker on the opening of toothpaste tube;
④When the electric dispenser is turned on, press the Squeeze button to squeeze the toothpaste, release the button to stop squeezing, then apply the toothpaste to the toothbrush.
Dosage & Administration
adults and children 2 years of age and older:
Brush teeth thoroughly for at least 2 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Do not swallow. Spit out after brushing.
children 2 to 6 years of age:
Use a pea-sized amount and supervise brushing. Instruct in good brushing and rinsing habits
children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredient
A Tube: glycerin, hydrated silica, propylene glycol, calcium sodium
phosphosilicate, cocamidopropyl betaine, polyoxyl 15
hydroxystearate, PEG-20, aroma, hydroxyapatite, PVP, titanium
dioxide, zinc citrate, sucralose, carboxymethyl chitosan, triacetin.
B Tube: glycerin, water, hydrated silica,potassium nitrate, PEG-8,
betaine, cocamidopropyl betaine, aroma, sodium lauryl sulfate,
xanthan gum, sodium hydroxide, zinc citrate, strontium chloride
hexahydrate, carbomer, arginine, sucralose, sodium carbonate,
sodium bicarbonate, carboxymethyl chitosan, calcium aluminum
borosilicate, tin oxide, titanium dioxide, blue 2.
Indications & Usage
Uses
aids in the prevention of dental cavities.
helps reduce and builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Recent Major Changes
adults and children 2 years of age and older:
Brush teeth thoroughly for at least 2 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Do not swallow. Spit out after brushing.
children 2 to 6 years of age:
Use a pea-sized amount and supervise brushing. Instruct in good brushing and rinsing habits
children under 2 years of age: Consult a dentist or doctor.
Package Label.Principal Display Panel
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