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  5. Label Information: Universal Sensitive Anti-cavity Fluoride

FDA Label for Universal Sensitive 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

Universal Sensitive 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 Ingredients

Potassium Nitrate  5%

Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)


Otc - Purpose



Purpose

Antihypersensitivity

Anticavity


Indications & Usage



Uses

  • 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

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Dosage & Administration



Directions

  • adults and children 12 years of age and older
  • apply at least a 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
  • make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

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


Other



Other information

  • store in a cool, dry place.

Inactive Ingredient



Inactive Ingredients

Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

label - sensitive anti cavity

label - sensitive anti cavity


* Please review the disclaimer below.