Hyvee
FDA Label NDC 42507-554

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 42507-554). 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.

Label Section Quick Index

Active Ingredient

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

Purpose

Antigingivitis/Antiplaque

Uses

aids in the prevention of dental cavities

Warnings

Keep out of reach of children

Keep Out Of Reach Of Children.

If more than used for rinsin is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • ​Adults and children 6 years of age and older:
  • ​use once a day after brushing your teeth with toothpaste
  • vigorously swish 10 mL 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
  • supervise children as necessary until capable of using without supervision
  • ​Children under 6 years of age: consult a dentist or doctor.

Other Information

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

Inactive Ingredients

Calcium Disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Green 3 (CI 42053), Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water (Aqua), Yellow 5 (CI 19140).

Questions Or Comments?

1-800-289-8343

Label Copy

Image Of The Label (20568l)

Image Of The Label (20568l)

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