Active Ingredient(S)
Sodium Fluoride 0.25%
Bubble Gum Flavor For Kids 25g 50g Ointment
FDA Label NDC 85215-001
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 Bubble Gum Flavor For Kids 25g 50g (NDC 85215-001). 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
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.
Do Not Use
Do not apply on open skin wounds
Otc - When Using
In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Minimize swallowing
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
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 physician
Children 2 to 6 years
Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2years
Ask a dentist or physician
Other Information
Store in a cool place, below 86° F, away from heat
Do not use if quality seal is broken or missing
Do not use after the expiration date
Inactive Ingredients
Inactive ingredients Sorbitol, Aqua, Hydrated Silica,
PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose
Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin
Sodium, Sodium Pyrophosphate, FD&C Blue No.1.
Package Label - Principal Display Panel
1 (Label)
2 (Label1)
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