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  5. Label Information: Anti Cavity Fluoride

FDA Label for Anti Cavity Fluoride

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. OTHER
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti Cavity Fluoride Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.