Active Ingredient
Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride
Oral Projeqt O1 Toothpastetablets
FDA Label NDC 76058-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sungwon Pharmaceutical Co., Ltd. for the product Oral Projeqt O1 Toothpastetablets (NDC 76058-500). 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 ingredient, inactive ingredient, purpose, keep out of reach of children, warning, uses, indication & usage section, 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
Inactive Ingredient
D-Sorbitol, Microcrystalline Cellulose, Sodium Chloride, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, GreenTea Flavor Powder, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Peppermint Flavor Powder), L-Menthol, Lemon Juice, Aloe Extract Powder, Tea Extract, Hydroxyapatite, Xanthan Gum, Hydroxypropylcellulose, Sodium Bicarbonate, Magnesium Stearate
Purpose
Helps protect against cavities and freshen breath.
Keep Out Of Reach Of Children
Keep out of reach of children.
Warning
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 immediately.
This toothpaste contains 1000ppm of fluorine.
If children under 6 years of age swallowed an over dose, get
medical help or contact a Poison Control Center immediately.
Uses
for oral use only
Indication & Usage Section
Adults and children 6 years of age and older
Literally chew a tablet then brush teeeth thoroughly,
preferably after each meal or at least twice a day, every day,
or as directed by a dentist or physician.
DO NOT swallow a tablet.
Children under 6 years of age: Consult a dentist or doctor.
Package Label.Principal Display Panel
1 (Label)
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