Active Ingredient(S)
Sodium fluoride 0.25% (100PPM)
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry Ointment
FDA Label NDC 85215-002
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 Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry (NDC 85215-002). 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
Use helps protect against cavities
Warnings
When using this product
Do not swallow
Do not use in eye area
Do Not Use
Do not use in eye area
Otc - When Using
When using this product
Do not swallow
Otc - Stop Use
When using this product keep out of eyes
Otc - Keep Out Of Reach Of Children
Keep out of Teach 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.
Directions
Directions ■Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after
each meal or at east twice a day, or use as directed by a dentist or doctor.
■Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
■Supervise children as necessary until capable of using without supervision.
■Children under 2 years of age: Consult a dentist or doctor.
Other Information
Store in a cool and shady place
Inactive Ingredients
Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroy| Sarcosinate, Fragrancel Flavor, Nano-Hydroxyapatite, Xanthan
Gum, Menthol, Sodium Benzoate, CarboxymethyI Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP-H202).
Package Label - Principal Display Panel
、
* Please review the disclaimer below.
