Rorobell Wawa Sensitive Teeth Tooth Paste, Dentifrice
FDA Label NDC 81275-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rorobell for the product Rorobell Wawa Sensitive Teeth Tooth (NDC 81275-014). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients

Hydrated Silica 18.5%

Potassium Nitrate 5.0%

Sodium Fluoride 0.3152%

Otc - Purpose

Purpose

Anti-plaque

Protection of sensitive teeth

Anti-cavity

Indications & Usage

Uses

■ Helps keep teeth white and strong.

■ Helps keep the oral cavity clean.

■ Helps freshen the oral cavity.

■ Helps eliminate bad breath.

■ Helps improve the appearance of teeth.

■ Helps prevent and relieve tooth sensitivity.

■ Helps remove dental plaque (anti-plaque).

■ Helps prevent cavities with fluoride.

Warnings

Warnings

Do not use this product

■ Do not use this product if you are hypersensitive or allergic to any of its ingredients.

When using this product

■ Use this product only for brushing teeth.

Stop use and ask a physician, dentist, or pharmacist if

Bring the product information with you whenever possible when seeking medical advice.

■ Irritation develops after using this product.

■ Swelling of the mouth or face occurs. This may be a sign of a very rare allergic reaction.

Other warnings

■ This toothpaste contains 1,426 ppm fluoride.

■ Because this toothpaste contains potassium nitrate, consult a physician or dentist before use in children under 12 years of age.

■ Do not swallow this toothpaste. Rinse your mouth thoroughly after use.

■ Children under 6 years of age should use only a pea-sized amount of toothpaste under adult supervision to prevent sucking or swallowing the toothpaste.

■ If a child under 6 years of age swallows a large amount of this toothpaste, consult a physician or dentist immediately.

■ Tooth sensitivity may indicate an underlying condition that requires prompt treatment. If symptoms persist or worsen, consult a dentist.

■ Because this toothpaste contains more than 1,000 ppm fluoride, consult a physician or dentist before use in children under 6 years of age.

■ As with other oral care products, discontinue use if irritation develops.

Storage

■ Keep out of reach of children under 6 years of age.

■ Store this product in its original container with the cap tightly closed. Do not transfer it to another container, as doing so may result in accidental misuse or reduce the quality of the product.

Otc - Keep Out Of Reach Of Children

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Dosage & Administration

Directions

■ Brush teeth twice daily by applying an appropriate amount of toothpaste to a toothbrush.

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