Universal Anti-cavity Fluoride Paste
FDA Label NDC 52000-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Universal Anti-cavity Fluoride (NDC 52000-111). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Sodium Monofluorophosphate  0.76%

(1000 ppm)

Otc - Purpose

Purpose

Anticavity toothpaste

Indications & Usage

Uses

  • regular brushing with flouride toothpaste helps protect teeth against cavities
  • aids in the prevention of dental cavities.

Warnings

Warning

Otc - When Using

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

Otc - Stop Use

Stop and ask a dentist

  • if the problem persists or worsens.

    • Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age

  • If accidentally swallowed get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • adults and children of 2 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
  • do not swallow.
  • to minimize swallowing, use a pea-sized amount in children under 6 years old.
  • supervise children's brushing until good habits are established.
  • children under 2 years: ask a dentist before use.

    • Children under 12 years of age: Consult a dentist or doctor

Other

Other information

  • store in a cool, dry place.

Inactive Ingredient

Inactive Ingredients

Calcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose and Flavor

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

UNIVERSAL ANTI-CAVITY FLUORIDE TOOTHPASTE

Label (Anti Cavity)

Label (Anti Cavity)

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