1. Home
  2. Labeler Index
  3. Universal Distribution Center Llc
  4. 52000-112
  5. Label Information: Universal Advanced Whitening Anti-cavity Fluoride

FDA Label for Universal Advanced Whitening 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 Advanced Whitening 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%

(1000 ppm)


Otc - Purpose



Purpose

Anticavity toothpaste


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 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, Flavor and FD&C blue #1


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

label - advanced whitening

label - advanced whitening


* Please review the disclaimer below.