Medichoice Premium Anticavity Fluoride Paste, Dentifrice
FDA Label NDC 39892-0603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O&m Halyard, Inc. for the product Medichoice Premium Anticavity Fluoride (NDC 39892-0603). 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 medichoice premium anticavity fluoride toothpaste, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Medichoice Premium Anticavity Fluoride Toothpaste

Drug Facts

Active Ingredient

Sodium Fluoride - 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and olden Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years of age should use only a pea-sized amount in order to minimize swallowing. Supervise children and help them create good brushing and rinsing habits until capable of using without supervision.
  • Children under 2 years of age: Consult a dentist or a doctor.

Inactive Ingredients

sorbitol, silica, water, glycerin, polythelene glycol 1500, sodium lauryl sulfate, flavor, titanium dioxide, cellulose gum, carrageenan, trisodium orthophosphate, sodium saccharin, sodium benzoate, tetrasodium pyrophosphate, methylparaben, propylparaben, FD & C blue #1

Made in India, Distributed by Owens & Minor, 9120 Lockwood Boulevard, Mechanicsville, VA 23116

C.No. DNH/COS/DNH/52
Exp. Date & Lot No. on Crimp Rev. A

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