Closys Rinse
FDA Label NDC 58578-1234

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rowpar Pharmaceuticals, Inc. for the product Closys (NDC 58578-1234). 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 drug facts, active ingredient, purpose, directions, inactive ingredients, other information, packaging, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Directions

Adults and Children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • remove cap
  • pour out and vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and 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 doctor

Inactive Ingredients

water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose

Other Information

  • do not use if safety seal is broken or missing

Packaging

16oz (16oz 1)

16oz (16oz 1)

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