Universal Advanced Whitening Anti-cavity Fluoride Toothpaste

Universal Advanced Whitening Anti-cavity Fluoride Toothpaste
SPL v2
SPL
SPL Set ID 8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e
Route
DENTAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Water Glycerin Silicon Dioxide Sodium Lauryl Sulfate Sorbitol Xanthan Gum Saccharin Sodium Sodium Benzoate Carboxymethylcellulose Sodium, Unspecified Form Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-18
Description

Active Ingredient Sodium Monofluorophosphate  0.76% (1000 ppm)

Medication Information

Warnings and Precautions

Warning

Indications and 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.
Dosage and 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

Description

Active Ingredient Sodium Monofluorophosphate  0.76% (1000 ppm)

Section 42229-5

Other information

  • store in a cool, dry place.
Section 50565-1

Keep out of reach of children

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Section 50566-9

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.

Section 50567-7

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6

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

Section 51945-4

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1

Purpose

Anticavity toothpaste

Section 55106-9

Active Ingredient

Sodium Monofluorophosphate  0.76%

(1000 ppm)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warning

Section 42229-5 (42229-5)

Other information

  • store in a cool, dry place.
Section 50565-1 (50565-1)

Keep out of reach of children

  • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1 (55105-1)

Purpose

Anticavity toothpaste

Section 55106-9 (55106-9)

Active Ingredient

Sodium Monofluorophosphate  0.76%

(1000 ppm)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:22.557644 · Updated: 2026-03-14T23:01:53.224533