Chewpaste With Fluoride
FDA Label NDC 81048-008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 2557807 Ontario Inc for the product Chewpaste With Fluoride (NDC 81048-008). 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 ingredients:, purpose:, uses:, directions:, storage:, non active ingredients:, warning:, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients:

0.25% Sodium fluoride (1.2mg)/tablet

Purpose:

Dentifrice

Uses:

Helps prevent tooth decay

Directions:

Adults and children over 6 years of age: 1 tablet, 2 times per day • Do not swallow • Pop 1 tablet in your mouth and chew, wet your toothbrush and brush normally • Repeat every morning and night • Consult a healthcare professional before using on children under 6 years

Storage:

Store in a tightly closed container in a cool, dry place

Non Active Ingredients:

Dicalcium phosphate, Kaolin, Xylitol, Erythritol, Magnesium stearate, Sodium lauryl sulfoacetate, Sodium bicarbonate, Mint flavour, Hydroxypropyl methylcellulose, Clay, Vanilla flavour, Eucalyptol, Xanthan gum, Citric acid, Menthol

Warning:

• If swallowed, call a poison control centre or get medical help right away

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Packaging

Image (810480 08 1)

Image (810480 08 1)

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