Anti Cavity Fluoride
FDA Label NDC 52000-036

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 Anti Cavity Fluoride (NDC 52000-036). 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%

(Total Fluoride Content - 1000 ppm approx.)

Otc - Purpose

Purpose

Anticavity toothpaste

Indications & Usage

Uses

  • regular brushing with flouride toothpaste helps protect teeth againts builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • 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 6 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 pea-sized amount in children under 6 years old.
  • supervise child's brushing until good habits are established.
  • children under 2 years: ask a dentist before use.

Other

Other information

  • store in a cool, dry place.

Inactive Ingredient

Inactive Ingredients

calcium carbonate, flavor, methylparaben, poly ethylene glycol 400, precipited silica, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, tetra sodium pyrophosphate, titanium dioxide, water.

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

ANTI-CAVITY FLUORIDE TOOTHPASTE

Label (Anti Cavity)

Label (Anti Cavity)

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