Inactives
Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring
Dye
Nafrinse Packetskit Mint
FDA Label NDC 0273-8007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Young Dental Manufacturing Co 1, Llc. for the product Nafrinse Packetskit Mint (NDC 0273-8007). 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 inactives, warning:, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warning:
This Packet contains sodium fluoride powder, contents poisonous if swallowed. keep away from children. Store in a dry place at controlled room temperature. For professional use only.
DO NOT SWALLOW
MISSUSE If child swallows dispensed amount of mouth rinse in a cup:
1. Do not panic -this amount should not hurt the child
2. In rare cases the child may feel slightly nauseous.
The child may have a serving of milk or ice cream to relieve the nausea. EMERGENCY TREATMENT If a child swallows more than one dispensed amount in a cup or powder contents of the fluoride mouth rinse packet call the Poison Control Center at 800-222-1222
Directions
Mix contents with stated amount of tap water until dissolved (read directions on jug label) Makes an 0.2 % solution of sodium fluoride mouthrinse aftert dilution. Swish 10 ml (2 teaspoons) around vigorously in the mouth for one minute and then spit out. To be used once a week.
* Please review the disclaimer below.
