Treatment Rinse
FDA Label NDC 61578-314

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dental Alliance Holdings Llc for the product Treatment Rinse (NDC 61578-314). 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:, use:, warnings:, directions:, inactive ingredients:, treatment rinse mint and apple enclosure and carton labels:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Sodium Fluoride 0.05% when mixed with part B

Purpose:

Anticavity

Use:

Aids in the prevention of dental caries (cavities)

Warnings:

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If you experience any unusual symptoms, stop use and contact your dentist.

Keep out of reach of children.

Directions:

Do not use before mixing with Part B. Adults and children 6 years of age and older: Use once daily after brushing. Shake each bottle before use. Using the measuring cup, combine 5 mL of component A with 5 mL of component B (10 mL, total). Vigorously swish the combined 10 mL of rinse between teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or physician. Do not dilute. Do not use either component alone. Store below 30 degrees C (86 degrees F). Do not freeze.

Inactive Ingredients:

Menthol, Natural Flavors, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide, Sodium Hypochlorite, Water, Xylitol.

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