Active Ingredient(S)
Sodium fluoride 0.243%W/W
(equivalent to 1100 ppm f.)
Freshness Flower Rose Toothpaste100g Ointment
FDA Label NDC 85215-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by World Dentists Association America Limited for the product Freshness Flower Rose Toothpaste100g (NDC 85215-007). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
Helps protect against cavities.
Warnings
As with all fluoride toothpaste, keep out of reach
of children under 6 years old. If you accidentally
swallow more than used for brushing, get medical
help or call a Poison Control Center right away.
Do Not Use
Do not use in eye area
Otc - When Using
When using this product Do not swallow
Otc - Stop Use
If you have an allergic reaction after using this product, please stop using it immediately and see a doctor.
Otc - Keep Out Of Reach Of Children
Please keep it out of the reach of children.
Directions
Adults and children 2 years and over: Brush
teeth thoroughly after each meal or at least twice
a day, or as directed by a dentist or doctor.
Children under 6 years of age: Use a pea-sized
amount and supervise child's brushing and
rinsing (to minimize swallowing). For children
under 2 years of age: Ask a dentist or doctor.
Other Information
Store in a cool and shady place
Inactive Ingredients
Sorbitol,Water,Hydrated Silica, Glycerin,Sodium
Lauroyl Sarcosinate, Flavor/Aroma, Xanthan Gum,
Xylitol, Benzyl Alcohol, Sodium Fluoride,Cellulose
Gum, Tetrapotassium Pyrophosphate,Zinc Lactate,
Caprylyl Glycol, Pentylene Glycol, Benzoic Acid,
Methyl Diisopropyl Propionamide,Sodium
Gluconate, Disodium Hydrogen Phosphate,
Sucralose, Allura Red (Pigment).
Package Label - Principal Display Panel
label
Undefined (Label)
Undefined (Label1)
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