Hyvee
FDA Label NDC 42507-552

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc. for the product Hyvee (NDC 42507-552). 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 ingredient, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

Purpose

Antigingivitis/Antiplaque

Uses

to help reduce and prevent

  • plaque
  • gingivitis

Warnings

Do not use in children under 12 years of age

Keep Out Of Reach Of Children

If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions

  • Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
  • Do not swallow

Other Information

  • Store at room temperature
  • Cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive Ingredients

Water (Aqua), Sorbitol, Alcohol (21.6%), Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090).

Questions Or Comments?

1-800-289-8343

Label Copy

Image Of The Label (20574l)

Image Of The Label (20574l)

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