Otc - Active Ingredient
Active ingredients: Xylitol 2.0mL/20mL; Calcium Lactate 0.02mL/20mL
Kids Oral Care Strawberry Flavor Spray
FDA Label NDC 82711-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Toothfilm Inc. for the product Kids Oral Care Strawberry Flavor (NDC 82711-101). 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 - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients: Water, Glycerin, Sodium Levulinate, Sodium Anisate, Trehalose, Sodium Chloride, Dicalcium Phosphate, Silica, Calcium Oxide
Otc - Purpose
Purpose: Anticavity
Otc - Keep Out Of Reach Of Children
keep out of reach of children: For external use only. Keep out of reach of children. Avoidcontact with eyes. Discontinue use if signs of irritation or rash occur.
Indications & Usage
Helps protect against cavities. Spray 2 to 3 times towards children's teeth to prevent plaque build up and cavities.
Warnings
Warnings: Avoid spraying in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor or pharmacist if you have an allergic reaction to this product or any of its ingredients.
Dosage & Administration
Directions: Apply the spray on the kiddo's teeth surface to form a protective coating.Do not spit the spray out.Do not rinse with water after spray. This spray is not intend to replace brushing or flossing.
Otc - Questions
Question: [email protected]
Other Safety Information
Other: Store at 20°C to 25°C (68°F to 77°F) Use product within 90 days of opening.
Package Label.Principal Display Panel
Kids Oral Spray Strawberry Flavor (Label)
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